Paracetamol Discontinued - FDA Approved Drugs

FDA Approved Drugs Database
Paracetamol Discontinued

Paracetamol Discontinued

FDA approved drug product records including application numbers, product numbers, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Discontinued

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508
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Jan 17, 2025
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U.S. FDA
First Approval
Jan 01, 1982
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FDA Approved Drug Records (508 records)
Clear
1982
01 Jan
Discontinued Application: 85667

Drug Name

VICODIN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 01, 1982

85667 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 85667
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18060

Drug Name

ACEPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

Jan 01, 1982

18060 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18060
Product No.: 1

Product

Dosage Form: -
Strength: 120MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18060

Drug Name

ACEPHEN

Product Number

2

Dosage Form

-

Strength

650MG

Approval Date

Jan 01, 1982

18060 / 2

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18060
Product No.: 2

Product

Dosage Form: -
Strength: 650MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1986
18 Dec
Discontinued Application: 18060

Drug Name

ACEPHEN

Product Number

3

Dosage Form

-

Strength

325MG

Approval Date

Dec 18, 1986

18060 / 3

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18060
Product No.: 3

Product

Dosage Form: -
Strength: 325MG

Approval Date

Dec 18, 1986

Regulatory Status

Discontinued

1992
27 Mar
Discontinued Application: 72218

Drug Name

ACEPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

Mar 27, 1992

72218 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 72218
Product No.: 1

Product

Dosage Form: -
Strength: 120MG

Approval Date

Mar 27, 1992

Regulatory Status

Discontinued

1992
27 Mar
Discontinued Application: 72237

Drug Name

ACEPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Mar 27, 1992

72237 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 72237
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Mar 27, 1992

Regulatory Status

Discontinued

1992
27 Mar
Discontinued Application: 72344

Drug Name

ACEPHEN

Product Number

1

Dosage Form

-

Strength

325MG

Approval Date

Mar 27, 1992

72344 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 72344
Product No.: 1

Product

Dosage Form: -
Strength: 325MG

Approval Date

Mar 27, 1992

Regulatory Status

Discontinued

1987
12 May
Discontinued Application: 71010

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

May 12, 1987

71010 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 71010
Product No.: 1

Product

Dosage Form: -
Strength: 120MG

Approval Date

May 12, 1987

Regulatory Status

Discontinued

1987
12 May
Discontinued Application: 71011

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

May 12, 1987

71011 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 71011
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

May 12, 1987

Regulatory Status

Discontinued

2021
15 Jan
Discontinued Application: 206610

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

Jan 15, 2021

206610 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 206610
Product No.: 1

Product

Dosage Form: -
Strength: 1GM/VIAL

Approval Date

Jan 15, 2021

Regulatory Status

Discontinued

2018
31 May
Discontinued Application: 207035

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

May 31, 2018

207035 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 207035
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

May 31, 2018

Regulatory Status

Discontinued

2022
25 Oct
Discontinued Application: 216467

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

Oct 25, 2022

216467 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 216467
Product No.: 1

Product

Dosage Form: -
Strength: 1GM/100ML (10MG/ML)

Approval Date

Oct 25, 2022

Regulatory Status

Discontinued

1996
26 Apr
Discontinued Application: 40119

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Apr 26, 1996

40119 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40119
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Apr 26, 1996

Regulatory Status

Discontinued

1992
16 Jul
Discontinued Application: 81249

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jul 16, 1992

81249 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 81249
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jul 16, 1992

Regulatory Status

Discontinued

1992
16 Jul
Discontinued Application: 81250

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jul 16, 1992

81250 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 81250
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jul 16, 1992

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83871

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 01, 1982

83871 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 83871
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83872

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

83872 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 83872
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84360

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

84360 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84360
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85217

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;30MG

Approval Date

Jan 01, 1982

85217 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85217
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85288

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85288 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85288
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85363

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

85363 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85363
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85364

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;15MG

Approval Date

Jan 01, 1982

85364 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85364
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85365

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

85365 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85365
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85607

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

85607 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85607
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85676

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85676 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85676
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86549

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

86549 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 86549
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87006

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

87006 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87006
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87141

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

87141 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87141
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1985
18 Oct
Discontinued Application: 89183

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Oct 18, 1985

89183 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89183
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Oct 18, 1985

Regulatory Status

Discontinued

1985
18 Oct
Discontinued Application: 89184

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Oct 18, 1985

89184 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89184
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Oct 18, 1985

Regulatory Status

Discontinued

1985
18 Oct
Discontinued Application: 89185

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Oct 18, 1985

89185 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89185
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Oct 18, 1985

Regulatory Status

Discontinued

1986
19 May
Discontinued Application: 89253

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

May 19, 1986

89253 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89253
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

May 19, 1986

Regulatory Status

Discontinued

1986
19 May
Discontinued Application: 89254

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

May 19, 1986

89254 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89254
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

May 19, 1986

Regulatory Status

Discontinued

1992
27 Oct
Discontinued Application: 89450

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Oct 27, 1992

89450 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89450
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Oct 27, 1992

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 89478

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Mar 03, 1987

89478 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89478
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Mar 03, 1987

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 89479

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Mar 03, 1987

89479 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89479
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Mar 03, 1987

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 89480

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Mar 03, 1987

89480 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89480
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Mar 03, 1987

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 89481

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Mar 03, 1987

89481 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89481
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Mar 03, 1987

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 89482

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Mar 03, 1987

89482 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89482
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Mar 03, 1987

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 89483

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Mar 03, 1987

89483 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89483
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Mar 03, 1987

Regulatory Status

Discontinued

1994
28 Dec
Discontinued Application: 89997

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Dec 28, 1994

89997 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89997
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Dec 28, 1994

Regulatory Status

Discontinued

1994
28 Dec
Discontinued Application: 89998

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Dec 28, 1994

89998 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89998
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Dec 28, 1994

Regulatory Status

Discontinued

1994
28 Dec
Discontinued Application: 89999

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Dec 28, 1994

89999 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89999
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Dec 28, 1994

Regulatory Status

Discontinued

2011
10 Nov
Discontinued Application: 91238

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Nov 10, 2011

91238 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 91238
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Nov 10, 2011

Regulatory Status

Discontinued

1985
27 Mar
Discontinued Application: 88898

Drug Name

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Mar 27, 1985

88898 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 88898
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Mar 27, 1985

Regulatory Status

Discontinued

2016
30 Sep
Discontinued Application: 204209

Drug Name

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

325MG;30MG;16MG

Approval Date

Sep 30, 2016

204209 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 204209
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;30MG;16MG

Approval Date

Sep 30, 2016

Regulatory Status

Discontinued

2007
03 Apr
Discontinued Application: 40688

Drug Name

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

356.4MG;30MG;16MG

Approval Date

Apr 03, 2007

40688 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 40688
Product No.: 1

Product

Dosage Form: -
Strength: 356.4MG;30MG;16MG

Approval Date

Apr 03, 2007

Regulatory Status

Discontinued

2007
03 Apr
Discontinued Application: 40701

Drug Name

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

712.8MG;60MG;32MG

Approval Date

Apr 03, 2007

40701 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 40701
Product No.: 1

Product

Dosage Form: -
Strength: 712.8MG;60MG;32MG

Approval Date

Apr 03, 2007

Regulatory Status

Discontinued

1988
05 Oct
Discontinued Application: 89568

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Oct 05, 1988

89568 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 89568
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Oct 05, 1988

Regulatory Status

Discontinued

2003
27 Aug
Discontinued Application: 40511

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Aug 27, 2003

40511 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40511
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Aug 27, 2003

Regulatory Status

Discontinued

2005
29 Jul
Discontinued Application: 40601

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jul 29, 2005

40601 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40601
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jul 29, 2005

Regulatory Status

Discontinued

1984
13 Nov
Discontinued Application: 87629

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Nov 13, 1984

87629 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 87629
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Nov 13, 1984

Regulatory Status

Discontinued

1984
05 Dec
Discontinued Application: 88825

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Dec 05, 1984

88825 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 88825
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Dec 05, 1984

Regulatory Status

Discontinued

2002
22 Apr
Discontinued Application: 75929

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

Apr 22, 2002

75929 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Identifiers

Application No.: 75929
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG;30MG

Approval Date

Apr 22, 2002

Regulatory Status

Discontinued

2020
08 Jul
Discontinued Application: 204649

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

Jul 08, 2020

204649 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Identifiers

Application No.: 204649
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG;30MG

Approval Date

Jul 08, 2020

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83643

Drug Name

CAPITAL AND CODEINE

Product Number

1

Dosage Form

-

Strength

325MG;30MG

Approval Date

Jan 01, 1982

83643 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 83643
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1988
02 Mar
Discontinued Application: 89360

Drug Name

CO-GESIC

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Mar 02, 1988

89360 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89360
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Mar 02, 1988

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85640

Drug Name

CODEINE, ASPIRIN, APAP FORMULA NO. 2

Product Number

1

Dosage Form

-

Strength

150MG;180MG;15MG

Approval Date

Jan 01, 1982

85640 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Identifiers

Application No.: 85640
Product No.: 1

Product

Dosage Form: -
Strength: 150MG;180MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85639

Drug Name

CODEINE, ASPIRIN, APAP FORMULA NO. 3

Product Number

1

Dosage Form

-

Strength

150MG;180MG;30MG

Approval Date

Jan 01, 1982

85639 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Identifiers

Application No.: 85639
Product No.: 1

Product

Dosage Form: -
Strength: 150MG;180MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85638

Drug Name

CODEINE, ASPIRIN, APAP FORMULA NO. 4

Product Number

1

Dosage Form

-

Strength

150MG;180MG;60MG

Approval Date

Jan 01, 1982

85638 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Identifiers

Application No.: 85638
Product No.: 1

Product

Dosage Form: -
Strength: 150MG;180MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2003
10 Sep
Discontinued Application: 76429

Drug Name

DARVOCET A500

Product Number

1

Dosage Form

-

Strength

500MG;100MG

Approval Date

Sep 10, 2003

76429 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 76429
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;100MG

Approval Date

Sep 10, 2003

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17122

Drug Name

DARVOCET-N 100

Product Number

2

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jan 01, 1982

17122 / 2

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 17122
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17122

Drug Name

DARVOCET-N 50

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Jan 01, 1982

17122 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 17122
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85100

Drug Name

DOLENE AP-65

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

Jan 01, 1982

85100 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 85100
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;65MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
03 May
Discontinued Application: 87677

Drug Name

HY-PHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 03, 1982

87677 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 87677
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 03, 1982

Regulatory Status

Discontinued

2000
28 Apr
Discontinued Application: 40248

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Apr 28, 2000

40248 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40248
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Apr 28, 2000

Regulatory Status

Discontinued

2000
28 Apr
Discontinued Application: 40248

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

Apr 28, 2000

40248 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40248
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Apr 28, 2000

Regulatory Status

Discontinued

2000
31 May
Discontinued Application: 40355

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

May 31, 2000

40355 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40355
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

May 31, 2000

Regulatory Status

Discontinued

2003
22 Jan
Discontinued Application: 40432

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Jan 22, 2003

40432 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40432
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Jan 22, 2003

Regulatory Status

Discontinued

2003
25 Sep
Discontinued Application: 40482

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

Sep 25, 2003

40482 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40482
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML

Approval Date

Sep 25, 2003

Regulatory Status

Discontinued

2006
19 Jan
Discontinued Application: 40655

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Jan 19, 2006

40655 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40655
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Jan 19, 2006

Regulatory Status

Discontinued

2006
19 Jan
Discontinued Application: 40656

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Jan 19, 2006

40656 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40656
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Jan 19, 2006

Regulatory Status

Discontinued

2006
19 Jan
Discontinued Application: 40658

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Jan 19, 2006

40658 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40658
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Jan 19, 2006

Regulatory Status

Discontinued

2006
24 Mar
Discontinued Application: 40658

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Mar 24, 2006

40658 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40658
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Mar 24, 2006

Regulatory Status

Discontinued

2004
23 Jun
Discontinued Application: 40658

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Jun 23, 2004

40658 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40658
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Jun 23, 2004

Regulatory Status

Discontinued

2006
25 Aug
Discontinued Application: 40729

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Aug 25, 2006

40729 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40729
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Aug 25, 2006

Regulatory Status

Discontinued

2006
25 Aug
Discontinued Application: 40748

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Aug 25, 2006

40748 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40748
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Aug 25, 2006

Regulatory Status

Discontinued

2006
25 Aug
Discontinued Application: 40754

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Aug 25, 2006

40754 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40754
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Aug 25, 2006

Regulatory Status

Discontinued

2006
25 Aug
Discontinued Application: 40757

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

Aug 25, 2006

40757 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40757
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Aug 25, 2006

Regulatory Status

Discontinued

2006
28 Aug
Discontinued Application: 40769

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Aug 28, 2006

40769 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40769
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Aug 28, 2006

Regulatory Status

Discontinued

2007
23 Feb
Discontinued Application: 40813

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Feb 23, 2007

40813 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40813
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Feb 23, 2007

Regulatory Status

Discontinued

1987
12 Jun
Discontinued Application: 89554

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jun 12, 1987

89554 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89554
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jun 12, 1987

Regulatory Status

Discontinued

2011
24 Jan
Discontinued Application: 90415

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Jan 24, 2011

90415 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90415
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Jan 24, 2011

Regulatory Status

Discontinued

2011
24 Jan
Discontinued Application: 90415

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Jan 24, 2011

90415 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90415
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Jan 24, 2011

Regulatory Status

Discontinued

2011
24 Jan
Discontinued Application: 90415

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Jan 24, 2011

90415 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90415
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Jan 24, 2011

Regulatory Status

Discontinued

2012
25 Jan
Discontinued Application: 200343

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

Jan 25, 2012

200343 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 200343
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML

Approval Date

Jan 25, 2012

Regulatory Status

Discontinued

2016
05 Jul
Discontinued Application: 205001

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Jul 05, 2016

205001 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 205001
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Jul 05, 2016

Regulatory Status

Discontinued

2016
05 Jul
Discontinued Application: 205001

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Jul 05, 2016

205001 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 205001
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Jul 05, 2016

Regulatory Status

Discontinued

2016
05 Jul
Discontinued Application: 205001

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Jul 05, 2016

205001 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 205001
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Jul 05, 2016

Regulatory Status

Discontinued

2017
23 Jun
Discontinued Application: 206869

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Jun 23, 2017

206869 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206869
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Jun 23, 2017

Regulatory Status

Discontinued

2020
07 Feb
Discontinued Application: 211690

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Feb 07, 2020

211690 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 211690
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Feb 07, 2020

Regulatory Status

Discontinued

2020
07 Feb
Discontinued Application: 211690

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Feb 07, 2020

211690 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 211690
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Feb 07, 2020

Regulatory Status

Discontinued

2020
07 Feb
Discontinued Application: 211690

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

Feb 07, 2020

211690 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 211690
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Feb 07, 2020

Regulatory Status

Discontinued

1986
07 Mar
Discontinued Application: 17785

Drug Name

INJECTAPAP

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

Mar 07, 1986

17785 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 17785
Product No.: 1

Product

Dosage Form: -
Strength: 100MG/ML

Approval Date

Mar 07, 1986

Regulatory Status

Discontinued

1986
14 Jan
Discontinued Application: 89115

Drug Name

MEDIGESIC PLUS

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jan 14, 1986

89115 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89115
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jan 14, 1986

Regulatory Status

Discontinued

1986
15 May
Discontinued Application: 88871

Drug Name

NORCET

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 15, 1986

88871 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 88871
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 15, 1986

Regulatory Status

Discontinued

2010
02 Nov
Discontinued Application: 22450

Drug Name

OFIRMEV

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Nov 02, 2010

22450 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 22450
Product No.: 1

Product

Dosage Form: -
Strength: 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Nov 02, 2010

Regulatory Status

Discontinued

1996
30 Jul
Discontinued Application: 40105

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Jul 30, 1996

40105 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40105
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Jul 30, 1996

Regulatory Status

Discontinued

2007
27 Nov
Discontinued Application: 40789

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Nov 27, 2007

40789 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40789
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Nov 27, 2007

Regulatory Status

Discontinued

2007
27 Nov
Discontinued Application: 40789

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Nov 27, 2007

40789 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40789
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Nov 27, 2007

Regulatory Status

Discontinued

1989
04 May
Discontinued Application: 89994

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 04, 1989

89994 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 89994
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 04, 1989

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 90177

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Oct 20, 2008

90177 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90177
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Oct 20, 2008

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 90177

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

Oct 20, 2008

90177 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90177
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Oct 20, 2008

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 90177

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Oct 20, 2008

90177 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90177
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Oct 20, 2008

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 90177

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

Oct 20, 2008

90177 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90177
Product No.: 4

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Oct 20, 2008

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 90177

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

5

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Oct 20, 2008

90177 / 5

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90177
Product No.: 5

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Oct 20, 2008

Regulatory Status

Discontinued

2008
20 Oct
Discontinued Application: 90177

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

6

Dosage Form

-

Strength

650MG;10MG

Approval Date

Oct 20, 2008

90177 / 6

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90177
Product No.: 6

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Oct 20, 2008

Regulatory Status

Discontinued

2013
11 Jul
Discontinued Application: 90733

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Jul 11, 2013

90733 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90733
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Jul 11, 2013

Regulatory Status

Discontinued

2013
11 Jul
Discontinued Application: 90734

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Jul 11, 2013

90734 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90734
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Jul 11, 2013

Regulatory Status

Discontinued

2013
11 Jul
Discontinued Application: 90734

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

Jul 11, 2013

90734 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90734
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Jul 11, 2013

Regulatory Status

Discontinued

2021
26 Aug
Discontinued Application: 201448

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML

Approval Date

Aug 26, 2021

201448 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 201448
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/5ML;5MG/5ML

Approval Date

Aug 26, 2021

Regulatory Status

Discontinued

2016
13 Dec
Discontinued Application: 207574

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Dec 13, 2016

207574 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 207574
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Dec 13, 2016

Regulatory Status

Discontinued

2019
15 Aug
Discontinued Application: 207834

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Aug 15, 2019

207834 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 207834
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Aug 15, 2019

Regulatory Status

Discontinued

2019
15 Aug
Discontinued Application: 207834

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Aug 15, 2019

207834 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 207834
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Aug 15, 2019

Regulatory Status

Discontinued

2019
15 Aug
Discontinued Application: 207834

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

Aug 15, 2019

207834 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 207834
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Aug 15, 2019

Regulatory Status

Discontinued

2014
18 Dec
Discontinued Application: 203573

Drug Name

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML

Approval Date

Dec 18, 2014

203573 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 203573
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/5ML;5MG/5ML

Approval Date

Dec 18, 2014

Regulatory Status

Discontinued

1984
20 Mar
Discontinued Application: 88037

Drug Name

PAPA-DEINE #3

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Mar 20, 1984

88037 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88037
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Mar 20, 1984

Regulatory Status

Discontinued

1984
20 Mar
Discontinued Application: 88715

Drug Name

PAPA-DEINE #4

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Mar 20, 1984

88715 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88715
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Mar 20, 1984

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85106

Drug Name

PERCOCET

Product Number

2

Dosage Form

-

Strength

325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

85106 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 85106
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84444

Drug Name

PHENAPHEN W/ CODEINE NO. 2

Product Number

1

Dosage Form

-

Strength

325MG;15MG

Approval Date

Jan 01, 1982

84444 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84444
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84445

Drug Name

PHENAPHEN W/ CODEINE NO. 3

Product Number

1

Dosage Form

-

Strength

325MG;30MG

Approval Date

Jan 01, 1982

84445 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84445
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84446

Drug Name

PHENAPHEN W/ CODEINE NO. 4

Product Number

1

Dosage Form

-

Strength

325MG;60MG

Approval Date

Jan 01, 1982

84446 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84446
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85856

Drug Name

PHENAPHEN-650 W/ CODEINE

Product Number

1

Dosage Form

-

Strength

650MG;30MG

Approval Date

Jan 01, 1982

85856 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85856
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1987
06 Jan
Discontinued Application: 71319

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jan 06, 1987

71319 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 71319
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jan 06, 1987

Regulatory Status

Discontinued

1988
13 May
Discontinued Application: 72105

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

May 13, 1988

72105 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 72105
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

May 13, 1988

Regulatory Status

Discontinued

1988
13 May
Discontinued Application: 72106

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

May 13, 1988

72106 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 72106
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

May 13, 1988

Regulatory Status

Discontinued

2004
07 May
Discontinued Application: 76743

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;100MG

Approval Date

May 07, 2004

76743 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 76743
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;100MG

Approval Date

May 07, 2004

Regulatory Status

Discontinued

2004
28 Jun
Discontinued Application: 76750

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;100MG

Approval Date

Jun 28, 2004

76750 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 76750
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;100MG

Approval Date

Jun 28, 2004

Regulatory Status

Discontinued

1985
17 Oct
Discontinued Application: 88944

Drug Name

SEDAPAP

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

Oct 17, 1985

88944 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 88944
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;50MG

Approval Date

Oct 17, 1985

Regulatory Status

Discontinued

1986
14 May
Discontinued Application: 89166

Drug Name

SYNALGOS-DC-A

Product Number

1

Dosage Form

-

Strength

356.4MG;30MG;16MG

Approval Date

May 14, 1986

89166 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 89166
Product No.: 1

Product

Dosage Form: -
Strength: 356.4MG;30MG;16MG

Approval Date

May 14, 1986

Regulatory Status

Discontinued

1982
23 Sep
Discontinued Application: 18458

Drug Name

TALACEN

Product Number

1

Dosage Form

-

Strength

650MG;EQ 25MG BASE

Approval Date

Sep 23, 1982

18458 / 1

Active Ingredient

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

Identifiers

Application No.: 18458
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;EQ 25MG BASE

Approval Date

Sep 23, 1982

Regulatory Status

Discontinued

2005
21 Apr
Discontinued Application: 76475

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

Apr 21, 2005

76475 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 76475
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG

Approval Date

Apr 21, 2005

Regulatory Status

Discontinued

2006
26 Jul
Discontinued Application: 76914

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

Jul 26, 2006

76914 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 76914
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG

Approval Date

Jul 26, 2006

Regulatory Status

Discontinued

2014
07 Apr
Discontinued Application: 78778

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

Apr 07, 2014

78778 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 78778
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG

Approval Date

Apr 07, 2014

Regulatory Status

Discontinued

1987
02 Jul
Discontinued Application: 89268

Drug Name

TRIAPRIN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Jul 02, 1987

89268 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 89268
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Jul 02, 1987

Regulatory Status

Discontinued

1986
27 Aug
Discontinued Application: 89385

Drug Name

TYCOLET

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Aug 27, 1986

89385 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89385
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Aug 27, 1986

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17756

Drug Name

TYLENOL

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Jan 01, 1982

17756 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 17756
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17756

Drug Name

TYLENOL

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

Jan 01, 1982

17756 / 2

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 17756
Product No.: 2

Product

Dosage Form: -
Strength: 120MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85056

Drug Name

TYLENOL W/ CODEINE

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

85056 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85056
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85056

Drug Name

TYLENOL W/ CODEINE

Product Number

2

Dosage Form

-

Strength

325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

85056 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85056
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85056

Drug Name

TYLENOL W/ CODEINE

Product Number

3

Dosage Form

-

Strength

325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

85056 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85056
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85056

Drug Name

TYLENOL W/ CODEINE

Product Number

4

Dosage Form

-

Strength

325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

85056 / 4

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85056
Product No.: 4

Product

Dosage Form: -
Strength: 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85057

Drug Name

TYLENOL W/ CODEINE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

85057 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85057
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87422

Drug Name

TYLENOL W/ CODEINE NO. 3

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

87422 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87422
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87421

Drug Name

TYLENOL W/ CODEINE NO. 4

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

87421 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87421
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85375

Drug Name

TYLOX

Product Number

1

Dosage Form

-

Strength

500MG;4.5MG;0.38MG

Approval Date

Jan 01, 1982

85375 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

Identifiers

Application No.: 85375
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;4.5MG;0.38MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1984
08 Nov
Discontinued Application: 88246

Drug Name

TYLOX-325

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Nov 08, 1984

88246 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 88246
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Nov 08, 1984

Regulatory Status

Discontinued

2016
14 Apr
Discontinued Application: 90468

Drug Name

ZYFREL

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

Apr 14, 2016

90468 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90468
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML

Approval Date

Apr 14, 2016

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40307

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;2.5MG

Approval Date

Jul 26, 2000

40307 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40307
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;2.5MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40307

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Jul 26, 2000

40307 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40307
Product No.: 2

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40307

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Jul 26, 2000

40307 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40307
Product No.: 3

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40307

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

650MG;10MG

Approval Date

Jul 26, 2000

40307 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40307
Product No.: 4

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40308

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 26, 2000

40308 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40308
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40308

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Jul 26, 2000

40308 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40308
Product No.: 2

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

2000
26 Jul
Discontinued Application: 40309

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Jul 26, 2000

40309 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40309
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Jul 26, 2000

Regulatory Status

Discontinued

1984
21 Dec
Discontinued Application: 88577

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 21, 1984

88577 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 88577
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 21, 1984

Regulatory Status

Discontinued

2000
02 Oct
Discontinued Application: 40304

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Oct 02, 2000

40304 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40304
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Oct 02, 2000

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87406

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Jan 01, 1982

87406 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 87406
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90265

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 23, 2008

90265 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90265
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90265

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Dec 23, 2008

90265 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90265
Product No.: 2

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90265

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

500MG;10MG

Approval Date

Dec 23, 2008

90265 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90265
Product No.: 3

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90380

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Dec 23, 2008

90380 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90380
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90380

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Dec 23, 2008

90380 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90380
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90380

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

660MG;10MG

Approval Date

Dec 23, 2008

90380 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90380
Product No.: 3

Product

Dosage Form: -
Strength: 660MG;10MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90380

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Dec 23, 2008

90380 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90380
Product No.: 4

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84999

Drug Name

WYGESIC

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

Jan 01, 1982

84999 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 84999
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;65MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2003
25 Aug
Discontinued Application: 40513

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Aug 25, 2003

40513 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40513
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Aug 25, 2003

Regulatory Status

Discontinued

1996
22 Feb
Discontinued Application: 40143

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

Feb 22, 1996

40143 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40143
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Feb 22, 1996

Regulatory Status

Discontinued

1996
22 Feb
Discontinued Application: 40144

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Feb 22, 1996

40144 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40144
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Feb 22, 1996

Regulatory Status

Discontinued

1997
25 Apr
Discontinued Application: 40144

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;2.5MG

Approval Date

Apr 25, 1997

40144 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40144
Product No.: 2

Product

Dosage Form: -
Strength: 500MG;2.5MG

Approval Date

Apr 25, 1997

Regulatory Status

Discontinued

1997
14 Apr
Discontinued Application: 40155

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Apr 14, 1997

40155 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40155
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Apr 14, 1997

Regulatory Status

Discontinued

1996
12 Apr
Discontinued Application: 40157

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Apr 12, 1996

40157 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40157
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Apr 12, 1996

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 40280

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Sep 30, 1998

40280 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40280
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Sep 30, 1998

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 40280

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Sep 30, 1998

40280 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40280
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Sep 30, 1998

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 40280

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

650MG;10MG

Approval Date

Sep 30, 1998

40280 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40280
Product No.: 3

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Sep 30, 1998

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 40281

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Sep 30, 1998

40281 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40281
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Sep 30, 1998

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 40281

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Sep 30, 1998

40281 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40281
Product No.: 2

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Sep 30, 1998

Regulatory Status

Discontinued

2000
31 May
Discontinued Application: 40356

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

May 31, 2000

40356 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40356
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

May 31, 2000

Regulatory Status

Discontinued

2000
31 May
Discontinued Application: 40358

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

660MG;10MG

Approval Date

May 31, 2000

40358 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40358
Product No.: 1

Product

Dosage Form: -
Strength: 660MG;10MG

Approval Date

May 31, 2000

Regulatory Status

Discontinued

2003
30 Oct
Discontinued Application: 40520

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

Oct 30, 2003

40520 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40520
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;7.5MG/15ML

Approval Date

Oct 30, 2003

Regulatory Status

Discontinued

1988
07 Sep
Discontinued Application: 89831

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Sep 07, 1988

89831 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89831
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Sep 07, 1988

Regulatory Status

Discontinued

1988
02 Dec
Discontinued Application: 89971

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 02, 1988

89971 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89971
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 02, 1988

Regulatory Status

Discontinued

1996
30 Jul
Discontinued Application: 40106

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 30, 1996

40106 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40106
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 30, 1996

Regulatory Status

Discontinued

1999
30 Dec
Discontinued Application: 40303

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 30, 1999

40303 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40303
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 30, 1999

Regulatory Status

Discontinued

1999
26 Jul
Discontinued Application: 40341

Drug Name

PERCOCET

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Jul 26, 1999

40341 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40341
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Jul 26, 1999

Regulatory Status

Discontinued

1999
26 Jul
Discontinued Application: 40341

Drug Name

PERCOCET

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Jul 26, 1999

40341 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40341
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Jul 26, 1999

Regulatory Status

Discontinued

2003
30 Jul
Discontinued Application: 40507

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

Jul 30, 2003

40507 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 40507
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;65MG

Approval Date

Jul 30, 2003

Regulatory Status

Discontinued

1997
12 Feb
Discontinued Application: 74843

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Feb 12, 1997

74843 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 74843
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Feb 12, 1997

Regulatory Status

Discontinued

2001
15 Feb
Discontinued Application: 74843

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;50MG

Approval Date

Feb 15, 2001

74843 / 2

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 74843
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Feb 15, 2001

Regulatory Status

Discontinued

1998
27 Nov
Discontinued Application: 40288

Drug Name

ZYDONE

Product Number

1

Dosage Form

-

Strength

400MG;5MG

Approval Date

Nov 27, 1998

40288 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40288
Product No.: 1

Product

Dosage Form: -
Strength: 400MG;5MG

Approval Date

Nov 27, 1998

Regulatory Status

Discontinued

1998
27 Nov
Discontinued Application: 40288

Drug Name

ZYDONE

Product Number

2

Dosage Form

-

Strength

400MG;7.5MG

Approval Date

Nov 27, 1998

40288 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40288
Product No.: 2

Product

Dosage Form: -
Strength: 400MG;7.5MG

Approval Date

Nov 27, 1998

Regulatory Status

Discontinued

1998
27 Nov
Discontinued Application: 40288

Drug Name

ZYDONE

Product Number

3

Dosage Form

-

Strength

400MG;10MG

Approval Date

Nov 27, 1998

40288 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40288
Product No.: 3

Product

Dosage Form: -
Strength: 400MG;10MG

Approval Date

Nov 27, 1998

Regulatory Status

Discontinued

1989
13 Jan
Discontinued Application: 89907

Drug Name

ALLAY

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 13, 1989

89907 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89907
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 13, 1989

Regulatory Status

Discontinued

1988
21 Apr
Discontinued Application: 89696

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Apr 21, 1988

89696 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89696
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Apr 21, 1988

Regulatory Status

Discontinued

1985
02 Aug
Discontinued Application: 70146

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Aug 02, 1985

70146 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70146
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Aug 02, 1985

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 40883

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Dec 23, 2008

40883 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40883
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
11 Feb
Discontinued Application: 77821

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Feb 11, 2008

77821 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 77821
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Feb 11, 2008

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85794

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85794 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85794
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85795

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 01, 1982

85795 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85795
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
13 Apr
Discontinued Application: 87653

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Apr 13, 1982

87653 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87653
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Apr 13, 1982

Regulatory Status

Discontinued

1997
25 Sep
Discontinued Application: 40236

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Sep 25, 1997

40236 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40236
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Sep 25, 1997

Regulatory Status

Discontinued

1997
25 Sep
Discontinued Application: 40236

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Sep 25, 1997

40236 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40236
Product No.: 2

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Sep 25, 1997

Regulatory Status

Discontinued

1997
26 Nov
Discontinued Application: 40240

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

Nov 26, 1997

40240 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40240
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Nov 26, 1997

Regulatory Status

Discontinued

1997
26 Nov
Discontinued Application: 40240

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Nov 26, 1997

40240 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40240
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Nov 26, 1997

Regulatory Status

Discontinued

1998
22 Jan
Discontinued Application: 40219

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 22, 1998

40219 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40219
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 22, 1998

Regulatory Status

Discontinued

1985
12 Jun
Discontinued Application: 70115

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Jun 12, 1985

70115 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70115
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Jun 12, 1985

Regulatory Status

Discontinued

1985
12 Jun
Discontinued Application: 70116

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jun 12, 1985

70116 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70116
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jun 12, 1985

Regulatory Status

Discontinued

1986
21 Mar
Discontinued Application: 70615

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Mar 21, 1986

70615 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70615
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Mar 21, 1986

Regulatory Status

Discontinued

1986
21 Mar
Discontinued Application: 70771

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Mar 21, 1986

70771 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70771
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Mar 21, 1986

Regulatory Status

Discontinued

1986
21 Mar
Discontinued Application: 70775

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Mar 21, 1986

70775 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70775
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Mar 21, 1986

Regulatory Status

Discontinued

2020
17 Jul
Discontinued Application: 211543

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jul 17, 2020

211543 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 211543
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jul 17, 2020

Regulatory Status

Discontinued

2002
23 Jan
Discontinued Application: 40366

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

Jan 23, 2002

40366 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40366
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;7.5MG/15ML

Approval Date

Jan 23, 2002

Regulatory Status

Discontinued

2017
28 Dec
Discontinued Application: 210079

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Dec 28, 2017

210079 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 210079
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Dec 28, 2017

Regulatory Status

Discontinued

2017
28 Dec
Discontinued Application: 210079

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

Dec 28, 2017

210079 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 210079
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Dec 28, 2017

Regulatory Status

Discontinued

2017
28 Dec
Discontinued Application: 210079

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Dec 28, 2017

210079 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 210079
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Dec 28, 2017

Regulatory Status

Discontinued

2017
28 Dec
Discontinued Application: 210079

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

Dec 28, 2017

210079 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 210079
Product No.: 4

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Dec 28, 2017

Regulatory Status

Discontinued

2016
14 Nov
Discontinued Application: 206142

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Nov 14, 2016

206142 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206142
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Nov 14, 2016

Regulatory Status

Discontinued

2016
14 Nov
Discontinued Application: 206142

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Nov 14, 2016

206142 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206142
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Nov 14, 2016

Regulatory Status

Discontinued

2016
14 Nov
Discontinued Application: 206142

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Nov 14, 2016

206142 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206142
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Nov 14, 2016

Regulatory Status

Discontinued

2016
01 Dec
Discontinued Application: 206245

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Dec 01, 2016

206245 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206245
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Dec 01, 2016

Regulatory Status

Discontinued

2016
01 Dec
Discontinued Application: 206245

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Dec 01, 2016

206245 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206245
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Dec 01, 2016

Regulatory Status

Discontinued

2016
01 Dec
Discontinued Application: 206245

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

Dec 01, 2016

206245 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206245
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Dec 01, 2016

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85218

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85218 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85218
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85992

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 01, 1982

85992 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85992
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87306

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

87306 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87306
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2006
22 Sep
Discontinued Application: 40637

Drug Name

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

712.8MG;60MG;32MG

Approval Date

Sep 22, 2006

40637 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 40637
Product No.: 1

Product

Dosage Form: -
Strength: 712.8MG;60MG;32MG

Approval Date

Sep 22, 2006

Regulatory Status

Discontinued

1997
14 Feb
Discontinued Application: 40148

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;10MG

Approval Date

Feb 14, 1997

40148 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40148
Product No.: 2

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Feb 14, 1997

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 40099

Drug Name

NORCO

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Jun 25, 1997

40099 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40099
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Jun 25, 1997

Regulatory Status

Discontinued

1997
14 Feb
Discontinued Application: 40148

Drug Name

NORCO

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

Feb 14, 1997

40148 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40148
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Feb 14, 1997

Regulatory Status

Discontinued

2000
12 Sep
Discontinued Application: 40148

Drug Name

NORCO

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Sep 12, 2000

40148 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40148
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Sep 12, 2000

Regulatory Status

Discontinued

2014
07 Jul
Discontinued Application: 40148

Drug Name

NORCO

Product Number

4

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Jul 07, 2014

40148 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40148
Product No.: 4

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Jul 07, 2014

Regulatory Status

Discontinued

2014
07 Jul
Discontinued Application: 40148

Drug Name

NORCO

Product Number

5

Dosage Form

-

Strength

325MG;5MG

Approval Date

Jul 07, 2014

40148 / 5

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40148
Product No.: 5

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Jul 07, 2014

Regulatory Status

Discontinued

1996
20 Sep
Discontinued Application: 40098

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Sep 20, 1996

40098 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40098
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Sep 20, 1996

Regulatory Status

Discontinued

1997
18 Nov
Discontinued Application: 40223

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Nov 18, 1997

40223 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40223
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Nov 18, 1997

Regulatory Status

Discontinued

1997
18 Nov
Discontinued Application: 40223

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

Nov 18, 1997

40223 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40223
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Nov 18, 1997

Regulatory Status

Discontinued

1997
18 Nov
Discontinued Application: 40223

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

Nov 18, 1997

40223 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40223
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Nov 18, 1997

Regulatory Status

Discontinued

1984
06 Feb
Discontinued Application: 88353

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Feb 06, 1984

88353 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88353
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Feb 06, 1984

Regulatory Status

Discontinued

1984
06 Feb
Discontinued Application: 88354

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Feb 06, 1984

88354 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88354
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Feb 06, 1984

Regulatory Status

Discontinued

1984
06 Feb
Discontinued Application: 88355

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Feb 06, 1984

88355 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88355
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Feb 06, 1984

Regulatory Status

Discontinued

1998
30 Jun
Discontinued Application: 40272

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Jun 30, 1998

40272 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40272
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Jun 30, 1998

Regulatory Status

Discontinued

1999
16 Mar
Discontinued Application: 40289

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Mar 16, 1999

40289 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40289
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Mar 16, 1999

Regulatory Status

Discontinued

2002
02 Aug
Discontinued Application: 76202

Drug Name

ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

650MG;EQ 25MG BASE

Approval Date

Aug 02, 2002

76202 / 1

Active Ingredient

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

Identifiers

Application No.: 76202
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;EQ 25MG BASE

Approval Date

Aug 02, 2002

Regulatory Status

Discontinued

1998
13 Mar
Discontinued Application: 40182

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

Mar 13, 1998

40182 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40182
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;7.5MG/15ML

Approval Date

Mar 13, 1998

Regulatory Status

Discontinued

1982
10 Dec
Discontinued Application: 87762

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Dec 10, 1982

87762 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87762
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Dec 10, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86681

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

86681 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 86681
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86683

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

86683 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 86683
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1986
17 Jul
Discontinued Application: 89080

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jul 17, 1986

89080 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89080
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jul 17, 1986

Regulatory Status

Discontinued

1988
10 Feb
Discontinued Application: 89673

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Feb 10, 1988

89673 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89673
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Feb 10, 1988

Regulatory Status

Discontinued

1988
10 Feb
Discontinued Application: 89673

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

Feb 10, 1988

89673 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89673
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Feb 10, 1988

Regulatory Status

Discontinued

1988
10 Feb
Discontinued Application: 89673

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

Feb 10, 1988

89673 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89673
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Feb 10, 1988

Regulatory Status

Discontinued

2018
30 Mar
Discontinued Application: 207808

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Mar 30, 2018

207808 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 207808
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Mar 30, 2018

Regulatory Status

Discontinued

2018
30 Mar
Discontinued Application: 207808

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Mar 30, 2018

207808 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 207808
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Mar 30, 2018

Regulatory Status

Discontinued

2018
30 Mar
Discontinued Application: 207808

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Mar 30, 2018

207808 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 207808
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Mar 30, 2018

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84656

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

84656 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84656
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84659

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 01, 1982

84659 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84659
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84667

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

84667 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 84667
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1989
25 Apr
Discontinued Application: 89511

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG;15MG

Approval Date

Apr 25, 1989

89511 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89511
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;15MG

Approval Date

Apr 25, 1989

Regulatory Status

Discontinued

1989
25 Apr
Discontinued Application: 89512

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG;30MG

Approval Date

Apr 25, 1989

89512 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89512
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;30MG

Approval Date

Apr 25, 1989

Regulatory Status

Discontinued

1989
25 Apr
Discontinued Application: 89513

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG;60MG

Approval Date

Apr 25, 1989

89513 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89513
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;60MG

Approval Date

Apr 25, 1989

Regulatory Status

Discontinued

1989
12 Jan
Discontinued Application: 89775

Drug Name

ROXICET 5/500

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 12, 1989

89775 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 89775
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 12, 1989

Regulatory Status

Discontinued

1995
03 Jul
Discontinued Application: 40061

Drug Name

ROXILOX

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 03, 1995

40061 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40061
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 03, 1995

Regulatory Status

Discontinued

1982
22 Jun
Discontinued Application: 87919

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jun 22, 1982

87919 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87919
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jun 22, 1982

Regulatory Status

Discontinued

1982
22 Jun
Discontinued Application: 87920

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jun 22, 1982

87920 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87920
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jun 22, 1982

Regulatory Status

Discontinued

1987
29 May
Discontinued Application: 89290

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 29, 1987

89290 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89290
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 29, 1987

Regulatory Status

Discontinued

1987
29 May
Discontinued Application: 89291

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 29, 1987

89291 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89291
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 29, 1987

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16844

Drug Name

DARVOCET

Product Number

1

Dosage Form

-

Strength

325MG;32.5MG

Approval Date

Jan 01, 1982

16844 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 16844
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;32.5MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1983
07 Jan
Discontinued Application: 88058

Drug Name

VICODIN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 07, 1983

88058 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 88058
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 07, 1983

Regulatory Status

Discontinued

1988
09 Dec
Discontinued Application: 89736

Drug Name

VICODIN ES

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Dec 09, 1988

89736 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89736
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Dec 09, 1988

Regulatory Status

Discontinued

1996
23 Sep
Discontinued Application: 40117

Drug Name

VICODIN HP

Product Number

1

Dosage Form

-

Strength

660MG;10MG

Approval Date

Sep 23, 1996

40117 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40117
Product No.: 1

Product

Dosage Form: -
Strength: 660MG;10MG

Approval Date

Sep 23, 1996

Regulatory Status

Discontinued

2003
22 Jan
Discontinued Application: 40443

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 22, 2003

40443 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40443
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 22, 2003

Regulatory Status

Discontinued

2003
22 Jan
Discontinued Application: 40443

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 22, 2003

40443 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40443
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 22, 2003

Regulatory Status

Discontinued

2003
22 Jan
Discontinued Application: 40443

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 22, 2003

40443 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40443
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 22, 2003

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85861

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

85861 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85861
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
26 May
Discontinued Application: 87275

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

May 26, 1982

87275 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87275
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

May 26, 1982

Regulatory Status

Discontinued

1982
26 May
Discontinued Application: 87276

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

May 26, 1982

87276 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87276
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

May 26, 1982

Regulatory Status

Discontinued

1982
26 May
Discontinued Application: 87277

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

May 26, 1982

87277 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87277
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

May 26, 1982

Regulatory Status

Discontinued

2000
24 Mar
Discontinued Application: 74699

Drug Name

ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

650MG;EQ 25MG BASE

Approval Date

Mar 24, 2000

74699 / 1

Active Ingredient

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

Identifiers

Application No.: 74699
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;EQ 25MG BASE

Approval Date

Mar 24, 2000

Regulatory Status

Discontinued

1984
19 Oct
Discontinued Application: 87550

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Oct 19, 1984

87550 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 87550
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Oct 19, 1984

Regulatory Status

Discontinued

1998
30 Jul
Discontinued Application: 40267

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Jul 30, 1998

40267 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40267
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Jul 30, 1998

Regulatory Status

Discontinued

1988
16 Feb
Discontinued Application: 89536

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Feb 16, 1988

89536 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89536
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Feb 16, 1988

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85883

Drug Name

CAPITAL AND CODEINE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

85883 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85883
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2003
27 Mar
Discontinued Application: 40441

Drug Name

CODRIX

Product Number

1

Dosage Form

-

Strength

500MG;30MG

Approval Date

Mar 27, 2003

40441 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40441
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;30MG

Approval Date

Mar 27, 2003

Regulatory Status

Discontinued

2003
26 Feb
Discontinued Application: 40447

Drug Name

CODRIX

Product Number

1

Dosage Form

-

Strength

500MG;15MG

Approval Date

Feb 26, 2003

40447 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40447
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;15MG

Approval Date

Feb 26, 2003

Regulatory Status

Discontinued

2003
28 Mar
Discontinued Application: 40488

Drug Name

CODRIX

Product Number

1

Dosage Form

-

Strength

500MG;60MG

Approval Date

Mar 28, 2003

40488 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40488
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;60MG

Approval Date

Mar 28, 2003

Regulatory Status

Discontinued

1995
29 Sep
Discontinued Application: 40094

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Sep 29, 1995

40094 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40094
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Sep 29, 1995

Regulatory Status

Discontinued

1995
29 Sep
Discontinued Application: 40094

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Sep 29, 1995

40094 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40094
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Sep 29, 1995

Regulatory Status

Discontinued

2000
08 Aug
Discontinued Application: 40094

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

660MG;10MG

Approval Date

Aug 08, 2000

40094 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40094
Product No.: 3

Product

Dosage Form: -
Strength: 660MG;10MG

Approval Date

Aug 08, 2000

Regulatory Status

Discontinued

1999
22 Mar
Discontinued Application: 40094

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

750MG;10MG

Approval Date

Mar 22, 1999

40094 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40094
Product No.: 4

Product

Dosage Form: -
Strength: 750MG;10MG

Approval Date

Mar 22, 1999

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 40122

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Mar 04, 1996

40122 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40122
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Mar 04, 1996

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 40122

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Mar 04, 1996

40122 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40122
Product No.: 2

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Mar 04, 1996

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 40123

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Mar 04, 1996

40123 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40123
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Mar 04, 1996

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 40123

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Mar 04, 1996

40123 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40123
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Mar 04, 1996

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 40123

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

500MG;2.5MG

Approval Date

Mar 04, 1996

40123 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40123
Product No.: 3

Product

Dosage Form: -
Strength: 500MG;2.5MG

Approval Date

Mar 04, 1996

Regulatory Status

Discontinued

1996
04 Mar
Discontinued Application: 40123

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Mar 04, 1996

40123 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40123
Product No.: 4

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Mar 04, 1996

Regulatory Status

Discontinued

2003
28 May
Discontinued Application: 40493

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 28, 2003

40493 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40493
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 28, 2003

Regulatory Status

Discontinued

2003
28 May
Discontinued Application: 40494

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

May 28, 2003

40494 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40494
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

May 28, 2003

Regulatory Status

Discontinued

2003
28 May
Discontinued Application: 40495

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

660MG;10MG

Approval Date

May 28, 2003

40495 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40495
Product No.: 1

Product

Dosage Form: -
Strength: 660MG;10MG

Approval Date

May 28, 2003

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 81079

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;2.5MG

Approval Date

Aug 30, 1991

81079 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81079
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;2.5MG

Approval Date

Aug 30, 1991

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 81080

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Aug 30, 1991

81080 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81080
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Aug 30, 1991

Regulatory Status

Discontinued

1991
30 Aug
Discontinued Application: 81083

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Aug 30, 1991

81083 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81083
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Aug 30, 1991

Regulatory Status

Discontinued

1988
01 Dec
Discontinued Application: 89883

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 01, 1988

89883 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89883
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 01, 1988

Regulatory Status

Discontinued

2016
02 Jun
Discontinued Application: 206470

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Jun 02, 2016

206470 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206470
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Jun 02, 2016

Regulatory Status

Discontinued

2016
02 Jun
Discontinued Application: 206470

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Jun 02, 2016

206470 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206470
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Jun 02, 2016

Regulatory Status

Discontinued

2016
02 Jun
Discontinued Application: 206470

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Jun 02, 2016

206470 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206470
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Jun 02, 2016

Regulatory Status

Discontinued

1997
30 Oct
Discontinued Application: 40171

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Oct 30, 1997

40171 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40171
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Oct 30, 1997

Regulatory Status

Discontinued

1998
30 Dec
Discontinued Application: 40199

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 30, 1998

40199 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40199
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 30, 1998

Regulatory Status

Discontinued

1999
15 Mar
Discontinued Application: 40203

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Mar 15, 1999

40203 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40203
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Mar 15, 1999

Regulatory Status

Discontinued

1997
30 Oct
Discontinued Application: 40234

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Oct 30, 1997

40234 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40234
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Oct 30, 1997

Regulatory Status

Discontinued

2000
29 Dec
Discontinued Application: 40371

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Dec 29, 2000

40371 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40371
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Dec 29, 2000

Regulatory Status

Discontinued

2000
29 Dec
Discontinued Application: 40371

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Dec 29, 2000

40371 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40371
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Dec 29, 2000

Regulatory Status

Discontinued

2003
05 Sep
Discontinued Application: 40535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Sep 05, 2003

40535 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40535
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Sep 05, 2003

Regulatory Status

Discontinued

2003
05 Sep
Discontinued Application: 40535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

Sep 05, 2003

40535 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40535
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Sep 05, 2003

Regulatory Status

Discontinued

2012
03 Apr
Discontinued Application: 40800

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Apr 03, 2012

40800 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40800
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Apr 03, 2012

Regulatory Status

Discontinued

2012
03 Apr
Discontinued Application: 40800

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

Apr 03, 2012

40800 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40800
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Apr 03, 2012

Regulatory Status

Discontinued

1996
16 Dec
Discontinued Application: 40139

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

Dec 16, 1996

40139 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 40139
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;65MG

Approval Date

Dec 16, 1996

Regulatory Status

Discontinued

1986
18 Dec
Discontinued Application: 70398

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Dec 18, 1986

70398 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70398
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Dec 18, 1986

Regulatory Status

Discontinued

1986
18 Dec
Discontinued Application: 70399

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Dec 18, 1986

70399 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70399
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Dec 18, 1986

Regulatory Status

Discontinued

1987
02 Jan
Discontinued Application: 70910

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jan 02, 1987

70910 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70910
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jan 02, 1987

Regulatory Status

Discontinued

2004
16 Nov
Discontinued Application: 76609

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Nov 16, 2004

76609 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 76609
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Nov 16, 2004

Regulatory Status

Discontinued

2005
28 Jun
Discontinued Application: 77196

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;100MG

Approval Date

Jun 28, 2005

77196 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 77196
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;100MG

Approval Date

Jun 28, 2005

Regulatory Status

Discontinued

2016
29 Nov
Discontinued Application: 207137

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;10MG

Approval Date

Nov 29, 2016

207137 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 207137
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Nov 29, 2016

Regulatory Status

Discontinued

1985
06 Mar
Discontinued Application: 88629

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Mar 06, 1985

88629 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88629
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Mar 06, 1985

Regulatory Status

Discontinued

1985
06 Mar
Discontinued Application: 88629

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

Mar 06, 1985

88629 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88629
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Mar 06, 1985

Regulatory Status

Discontinued

1985
06 Mar
Discontinued Application: 88629

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

Mar 06, 1985

88629 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88629
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Mar 06, 1985

Regulatory Status

Discontinued

1983
29 Dec
Discontinued Application: 88324

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Dec 29, 1983

88324 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88324
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Dec 29, 1983

Regulatory Status

Discontinued

1984
04 Jun
Discontinued Application: 88537

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jun 04, 1984

88537 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88537
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jun 04, 1984

Regulatory Status

Discontinued

1984
01 Jun
Discontinued Application: 88599

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jun 01, 1984

88599 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 88599
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jun 01, 1984

Regulatory Status

Discontinued

1985
12 Jun
Discontinued Application: 70107

Drug Name

PROPACET 100

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jun 12, 1985

70107 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70107
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jun 12, 1985

Regulatory Status

Discontinued

1986
03 Jan
Discontinued Application: 70732

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jan 03, 1986

70732 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70732
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jan 03, 1986

Regulatory Status

Discontinued

1994
19 Dec
Discontinued Application: 74119

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Dec 19, 1994

74119 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 74119
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Dec 19, 1994

Regulatory Status

Discontinued

1986
16 Jan
Discontinued Application: 88889

Drug Name

BANCAP

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Jan 16, 1986

88889 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 88889
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Jan 16, 1986

Regulatory Status

Discontinued

1983
17 Mar
Discontinued Application: 87961

Drug Name

BANCAP HC

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Mar 17, 1983

87961 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 87961
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Mar 17, 1983

Regulatory Status

Discontinued

1983
17 Mar
Discontinued Application: 87809

Drug Name

DURADYNE DHC

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Mar 17, 1983

87809 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 87809
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Mar 17, 1983

Regulatory Status

Discontinued

1988
23 Dec
Discontinued Application: 89660

Drug Name

ESGIC

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Dec 23, 1988

89660 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89660
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Dec 23, 1988

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83951

Drug Name

EMPRACET W/ CODEINE PHOSPHATE #3

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

83951 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 83951
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83951

Drug Name

EMPRACET W/ CODEINE PHOSPHATE #4

Product Number

2

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

83951 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 83951
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1998
28 Oct
Discontinued Application: 40261

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Oct 28, 1998

40261 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40261
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Oct 28, 1998

Regulatory Status

Discontinued

1999
18 Aug
Discontinued Application: 40336

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Aug 18, 1999

40336 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40336
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Aug 18, 1999

Regulatory Status

Discontinued

1995
12 Jun
Discontinued Application: 89718

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jun 12, 1995

89718 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89718
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jun 12, 1995

Regulatory Status

Discontinued

2022
25 Mar
Discontinued Application: 215135

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

300MG;50MG;40MG

Approval Date

Mar 25, 2022

215135 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 215135
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;50MG;40MG

Approval Date

Mar 25, 2022

Regulatory Status

Discontinued

2022
25 Mar
Discontinued Application: 215135

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Mar 25, 2022

215135 / 2

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 215135
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Mar 25, 2022

Regulatory Status

Discontinued

2001
23 Mar
Discontinued Application: 75618

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

Mar 23, 2001

75618 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Identifiers

Application No.: 75618
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG;30MG

Approval Date

Mar 23, 2001

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87003

Drug Name

ROXICET

Product Number

1

Dosage Form

-

Strength

325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

87003 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 87003
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1986
03 Dec
Discontinued Application: 89351

Drug Name

ROXICET

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Dec 03, 1986

89351 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 89351
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Dec 03, 1986

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 1

Product Number

1

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Jan 01, 1982

85055 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85055
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 2

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 01, 1982

85055 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85055
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 3

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85055 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85055
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 4

Product Number

4

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

85055 / 4

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85055
Product No.: 4

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 88790

Drug Name

TYLOX

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Dec 12, 1984

88790 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 88790
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Dec 12, 1984

Regulatory Status

Discontinued

2001
15 Aug
Discontinued Application: 21123

Drug Name

ULTRACET

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Aug 15, 2001

21123 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 21123
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Aug 15, 2001

Regulatory Status

Discontinued

2017
02 May
Discontinued Application: 206885

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

May 02, 2017

206885 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 206885
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG

Approval Date

May 02, 2017

Regulatory Status

Discontinued

2002
31 Oct
Discontinued Application: 40468

Drug Name

ANEXSIA

Product Number

1

Dosage Form

-

Strength

750MG;10MG

Approval Date

Oct 31, 2002

40468 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40468
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;10MG

Approval Date

Oct 31, 2002

Regulatory Status

Discontinued

1987
23 Apr
Discontinued Application: 89160

Drug Name

ANEXSIA

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Apr 23, 1987

89160 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89160
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Apr 23, 1987

Regulatory Status

Discontinued

1987
30 Sep
Discontinued Application: 89725

Drug Name

ANEXSIA 7.5/650

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Sep 30, 1987

89725 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89725
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Sep 30, 1987

Regulatory Status

Discontinued

1985
28 Jun
Discontinued Application: 88991

Drug Name

BUCET

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

Jun 28, 1985

88991 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 88991
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;50MG

Approval Date

Jun 28, 1985

Regulatory Status

Discontinued

1985
24 Jan
Discontinued Application: 87804

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jan 24, 1985

87804 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 87804
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jan 24, 1985

Regulatory Status

Discontinued

1985
18 Jul
Discontinued Application: 88743

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jul 18, 1985

88743 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 88743
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jul 18, 1985

Regulatory Status

Discontinued

1985
27 Mar
Discontinued Application: 88758

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Mar 27, 1985

88758 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 88758
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Mar 27, 1985

Regulatory Status

Discontinued

1985
27 Mar
Discontinued Application: 88765

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Mar 27, 1985

88765 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 88765
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Mar 27, 1985

Regulatory Status

Discontinued

1985
19 Apr
Discontinued Application: 89067

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Apr 19, 1985

89067 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89067
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Apr 19, 1985

Regulatory Status

Discontinued

1985
19 Jun
Discontinued Application: 89102

Drug Name

FEMCET

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jun 19, 1985

89102 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89102
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jun 19, 1985

Regulatory Status

Discontinued

1995
01 Jun
Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Jun 01, 1995

40084 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40084
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Jun 01, 1995

Regulatory Status

Discontinued

1995
01 Jun
Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jun 01, 1995

40084 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40084
Product No.: 2

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jun 01, 1995

Regulatory Status

Discontinued

1996
29 Jul
Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

660MG;10MG

Approval Date

Jul 29, 1996

40084 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40084
Product No.: 3

Product

Dosage Form: -
Strength: 660MG;10MG

Approval Date

Jul 29, 1996

Regulatory Status

Discontinued

1996
16 Oct
Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

650MG;10MG

Approval Date

Oct 16, 1996

40084 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40084
Product No.: 4

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Oct 16, 1996

Regulatory Status

Discontinued

1998
27 Feb
Discontinued Application: 40201

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Feb 27, 1998

40201 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40201
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Feb 27, 1998

Regulatory Status

Discontinued

1998
27 Feb
Discontinued Application: 40201

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;10MG

Approval Date

Feb 27, 1998

40201 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40201
Product No.: 2

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Feb 27, 1998

Regulatory Status

Discontinued

2001
27 Jun
Discontinued Application: 40418

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

Jun 27, 2001

40418 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40418
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;7.5MG/15ML

Approval Date

Jun 27, 2001

Regulatory Status

Discontinued

2003
29 Aug
Discontinued Application: 40508

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;10MG/15ML

Approval Date

Aug 29, 2003

40508 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40508
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;10MG/15ML

Approval Date

Aug 29, 2003

Regulatory Status

Discontinued

1985
19 Jul
Discontinued Application: 88956

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 19, 1985

88956 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 88956
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 19, 1985

Regulatory Status

Discontinued

1985
09 Aug
Discontinued Application: 89006

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Aug 09, 1985

89006 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89006
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Aug 09, 1985

Regulatory Status

Discontinued

1982
08 Jul
Discontinued Application: 87336

Drug Name

LORCET-HD

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 08, 1982

87336 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 87336
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 08, 1982

Regulatory Status

Discontinued

1998
04 Aug
Discontinued Application: 40257

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Aug 04, 1998

40257 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40257
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Aug 04, 1998

Regulatory Status

Discontinued

2004
30 Jun
Discontinued Application: 40550

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Jun 30, 2004

40550 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40550
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Jun 30, 2004

Regulatory Status

Discontinued

2004
30 Jun
Discontinued Application: 40550

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

Jun 30, 2004

40550 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40550
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Jun 30, 2004

Regulatory Status

Discontinued

2006
29 Sep
Discontinued Application: 40680

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML

Approval Date

Sep 29, 2006

40680 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40680
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/5ML;5MG/5ML

Approval Date

Sep 29, 2006

Regulatory Status

Discontinued

2001
02 Feb
Discontinued Application: 75738

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Feb 02, 2001

75738 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 75738
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Feb 02, 2001

Regulatory Status

Discontinued

1990
15 May
Discontinued Application: 89405

Drug Name

TENCON

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

May 15, 1990

89405 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 89405
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;50MG

Approval Date

May 15, 1990

Regulatory Status

Discontinued

1985
19 Jun
Discontinued Application: 89023

Drug Name

TRIAD

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jun 19, 1985

89023 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89023
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jun 19, 1985

Regulatory Status

Discontinued

2014
11 Mar
Discontinued Application: 204031

Drug Name

XARTEMIS XR

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Mar 11, 2014

204031 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 204031
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Mar 11, 2014

Regulatory Status

Discontinued

1987
22 May
Discontinued Application: 19453

Drug Name

DRIXORAL PLUS

Product Number

1

Dosage Form

-

Strength

500MG;3MG;60MG

Approval Date

May 22, 1987

19453 / 1

Active Ingredient

ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Identifiers

Application No.: 19453
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;3MG;60MG

Approval Date

May 22, 1987

Regulatory Status

Discontinued

2012
14 Dec
Discontinued Application: 201952

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

Dec 14, 2012

201952 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 201952
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG

Approval Date

Dec 14, 2012

Regulatory Status

Discontinued

1986
03 Mar
Discontinued Application: 89231

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

650MG;30MG

Approval Date

Mar 03, 1986

89231 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89231
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;30MG

Approval Date

Mar 03, 1986

Regulatory Status

Discontinued

1986
25 Feb
Discontinued Application: 89238

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Feb 25, 1986

89238 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89238
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Feb 25, 1986

Regulatory Status

Discontinued

1986
25 Feb
Discontinued Application: 89244

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Feb 25, 1986

89244 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89244
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Feb 25, 1986

Regulatory Status

Discontinued

1991
09 Sep
Discontinued Application: 89363

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

650MG;60MG

Approval Date

Sep 09, 1991

89363 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 89363
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;60MG

Approval Date

Sep 09, 1991

Regulatory Status

Discontinued

1990
26 Oct
Discontinued Application: 81095

Drug Name

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

150MG;180MG;15MG

Approval Date

Oct 26, 1990

81095 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Identifiers

Application No.: 81095
Product No.: 1

Product

Dosage Form: -
Strength: 150MG;180MG;15MG

Approval Date

Oct 26, 1990

Regulatory Status

Discontinued

1990
26 Oct
Discontinued Application: 81096

Drug Name

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

150MG;180MG;30MG

Approval Date

Oct 26, 1990

81096 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Identifiers

Application No.: 81096
Product No.: 1

Product

Dosage Form: -
Strength: 150MG;180MG;30MG

Approval Date

Oct 26, 1990

Regulatory Status

Discontinued

1990
26 Oct
Discontinued Application: 81097

Drug Name

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

150MG;180MG;60MG

Approval Date

Oct 26, 1990

81097 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Identifiers

Application No.: 81097
Product No.: 1

Product

Dosage Form: -
Strength: 150MG;180MG;60MG

Approval Date

Oct 26, 1990

Regulatory Status

Discontinued

1997
26 Aug
Discontinued Application: 40109

Drug Name

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

356.4MG;30MG;16MG

Approval Date

Aug 26, 1997

40109 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 40109
Product No.: 1

Product

Dosage Form: -
Strength: 356.4MG;30MG;16MG

Approval Date

Aug 26, 1997

Regulatory Status

Discontinued

1999
28 Apr
Discontinued Application: 40316

Drug Name

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

712.8MG;60MG;32MG

Approval Date

Apr 28, 1999

40316 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 40316
Product No.: 1

Product

Dosage Form: -
Strength: 712.8MG;60MG;32MG

Approval Date

Apr 28, 1999

Regulatory Status

Discontinued

2003
23 Dec
Discontinued Application: 40496

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

750MG;50MG;40MG

Approval Date

Dec 23, 2003

40496 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40496
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;50MG;40MG

Approval Date

Dec 23, 2003

Regulatory Status

Discontinued

1992
26 Oct
Discontinued Application: 89988

Drug Name

BUTAPAP

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

Oct 26, 1992

89988 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 89988
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;50MG

Approval Date

Oct 26, 1992

Regulatory Status

Discontinued

1996
28 Mar
Discontinued Application: 40085

Drug Name

ESGIC-PLUS

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Mar 28, 1996

40085 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40085
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Mar 28, 1996

Regulatory Status

Discontinued

1988
23 May
Discontinued Application: 89451

Drug Name

ESGIC-PLUS

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

May 23, 1988

89451 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 89451
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

May 23, 1988

Regulatory Status

Discontinued

2010
09 Jun
Discontinued Application: 40846

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Jun 09, 2010

40846 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40846
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Jun 09, 2010

Regulatory Status

Discontinued

2010
09 Jun
Discontinued Application: 40849

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;5MG

Approval Date

Jun 09, 2010

40849 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40849
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;5MG

Approval Date

Jun 09, 2010

Regulatory Status

Discontinued

1992
28 Aug
Discontinued Application: 81051

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

Aug 28, 1992

81051 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81051
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;7.5MG/15ML

Approval Date

Aug 28, 1992

Regulatory Status

Discontinued

1989
30 Nov
Discontinued Application: 81067

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Nov 30, 1989

81067 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81067
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Nov 30, 1989

Regulatory Status

Discontinued

1989
30 Nov
Discontinued Application: 81068

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Nov 30, 1989

81068 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81068
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Nov 30, 1989

Regulatory Status

Discontinued

1989
30 Nov
Discontinued Application: 81069

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Nov 30, 1989

81069 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81069
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Nov 30, 1989

Regulatory Status

Discontinued

1989
30 Nov
Discontinued Application: 81070

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Nov 30, 1989

81070 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81070
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Nov 30, 1989

Regulatory Status

Discontinued

1992
29 May
Discontinued Application: 81223

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

May 29, 1992

81223 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81223
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

May 29, 1992

Regulatory Status

Discontinued

1992
27 Oct
Discontinued Application: 81226

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;5MG/15ML

Approval Date

Oct 27, 1992

81226 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 81226
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;5MG/15ML

Approval Date

Oct 27, 1992

Regulatory Status

Discontinued

1986
21 Feb
Discontinued Application: 89008

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Feb 21, 1986

89008 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89008
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Feb 21, 1986

Regulatory Status

Discontinued

1986
16 Jul
Discontinued Application: 89271

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 16, 1986

89271 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89271
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 16, 1986

Regulatory Status

Discontinued

1992
29 Apr
Discontinued Application: 89557

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;5MG/15ML

Approval Date

Apr 29, 1992

89557 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89557
Product No.: 1

Product

Dosage Form: -
Strength: 500MG/15ML;5MG/15ML

Approval Date

Apr 29, 1992

Regulatory Status

Discontinued

1988
29 Jun
Discontinued Application: 89689

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Jun 29, 1988

89689 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89689
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Jun 29, 1988

Regulatory Status

Discontinued

1992
28 Jan
Discontinued Application: 89697

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 28, 1992

89697 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89697
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 28, 1992

Regulatory Status

Discontinued

1989
25 Aug
Discontinued Application: 89698

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;2.5MG

Approval Date

Aug 25, 1989

89698 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89698
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;2.5MG

Approval Date

Aug 25, 1989

Regulatory Status

Discontinued

1989
25 Aug
Discontinued Application: 89699

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

Aug 25, 1989

89699 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 89699
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

Aug 25, 1989

Regulatory Status

Discontinued

2006
19 Apr
Discontinued Application: 40676

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Apr 19, 2006

40676 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40676
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Apr 19, 2006

Regulatory Status

Discontinued

2006
16 May
Discontinued Application: 40679

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

400MG;2.5MG

Approval Date

May 16, 2006

40679 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40679
Product No.: 1

Product

Dosage Form: -
Strength: 400MG;2.5MG

Approval Date

May 16, 2006

Regulatory Status

Discontinued

2006
27 Apr
Discontinued Application: 40687

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

400MG;5MG

Approval Date

Apr 27, 2006

40687 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40687
Product No.: 1

Product

Dosage Form: -
Strength: 400MG;5MG

Approval Date

Apr 27, 2006

Regulatory Status

Discontinued

2006
27 Apr
Discontinued Application: 40692

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

400MG;10MG

Approval Date

Apr 27, 2006

40692 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40692
Product No.: 1

Product

Dosage Form: -
Strength: 400MG;10MG

Approval Date

Apr 27, 2006

Regulatory Status

Discontinued

2006
27 Apr
Discontinued Application: 40698

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

400MG;7.5MG

Approval Date

Apr 27, 2006

40698 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 40698
Product No.: 1

Product

Dosage Form: -
Strength: 400MG;7.5MG

Approval Date

Apr 27, 2006

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83689

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;32MG

Approval Date

Jan 01, 1982

83689 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 83689
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;32MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83978

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

Jan 01, 1982

83978 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 83978
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;65MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1985
12 Jun
Discontinued Application: 70145

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jun 12, 1985

70145 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70145
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jun 12, 1985

Regulatory Status

Discontinued

1988
16 Feb
Discontinued Application: 72195

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Feb 16, 1988

72195 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 72195
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Feb 16, 1988

Regulatory Status

Discontinued

2001
01 Mar
Discontinued Application: 21082

Drug Name

TAVIST ALLERGY/SINUS/HEADACHE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 0.25MG BASE;30MG

Approval Date

Mar 01, 2001

21082 / 1

Active Ingredient

ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Identifiers

Application No.: 21082
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;EQ 0.25MG BASE;30MG

Approval Date

Mar 01, 2001

Regulatory Status

Discontinued

2007
16 Aug
Discontinued Application: 40822

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Aug 16, 2007

40822 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40822
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Aug 16, 2007

Regulatory Status

Discontinued

2007
16 Aug
Discontinued Application: 40824

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Aug 16, 2007

40824 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40824
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Aug 16, 2007

Regulatory Status

Discontinued

2007
16 Aug
Discontinued Application: 40825

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Aug 16, 2007

40825 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40825
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Aug 16, 2007

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85291

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85291 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85291
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85917

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85917 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85917
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85964

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

85964 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85964
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87423

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Jan 01, 1982

87423 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87423
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87433

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

Jan 01, 1982

87433 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 87433
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;15MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1997
27 Jan
Discontinued Application: 40149

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 27, 1997

40149 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40149
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 27, 1997

Regulatory Status

Discontinued

1997
27 Jan
Discontinued Application: 40149

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Jan 27, 1997

40149 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40149
Product No.: 2

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Jan 27, 1997

Regulatory Status

Discontinued

1989
18 Jul
Discontinued Application: 89959

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

Jul 18, 1989

89959 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Identifiers

Application No.: 89959
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;65MG

Approval Date

Jul 18, 1989

Regulatory Status

Discontinued

1986
23 Jan
Discontinued Application: 70443

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jan 23, 1986

70443 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 70443
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jan 23, 1986

Regulatory Status

Discontinued

1995
27 Feb
Discontinued Application: 73106

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

Feb 27, 1995

73106 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 73106
Product No.: 1

Product

Dosage Form: -
Strength: 120MG

Approval Date

Feb 27, 1995

Regulatory Status

Discontinued

1995
27 Feb
Discontinued Application: 73107

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG

Approval Date

Feb 27, 1995

73107 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 73107
Product No.: 1

Product

Dosage Form: -
Strength: 325MG

Approval Date

Feb 27, 1995

Regulatory Status

Discontinued

1995
27 Feb
Discontinued Application: 73108

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Feb 27, 1995

73108 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 73108
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Feb 27, 1995

Regulatory Status

Discontinued

2011
14 Dec
Discontinued Application: 78569

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Dec 14, 2011

78569 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 78569
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Dec 14, 2011

Regulatory Status

Discontinued

2009
18 Nov
Discontinued Application: 90205

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Nov 18, 2009

90205 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 90205
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Nov 18, 2009

Regulatory Status

Discontinued

2002
01 Aug
Discontinued Application: 40452

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Aug 01, 2002

40452 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40452
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Aug 01, 2002

Regulatory Status

Discontinued

2002
01 Aug
Discontinued Application: 40459

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

Aug 01, 2002

40459 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 40459
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;60MG

Approval Date

Aug 01, 2002

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85868

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85868 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85868
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 40390

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jul 23, 2001

40390 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40390
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jul 23, 2001

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 40394

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

Jul 23, 2001

40394 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 40394
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;50MG;40MG

Approval Date

Jul 23, 2001

Regulatory Status

Discontinued

2003
21 Aug
Discontinued Application: 76528

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

Aug 21, 2003

76528 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Identifiers

Application No.: 76528
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG;30MG

Approval Date

Aug 21, 2003

Regulatory Status

Discontinued

2002
23 Oct
Discontinued Application: 40464

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Oct 23, 2002

40464 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40464
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Oct 23, 2002

Regulatory Status

Discontinued

2002
23 Oct
Discontinued Application: 40464

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

Oct 23, 2002

40464 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40464
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Oct 23, 2002

Regulatory Status

Discontinued

2002
25 Oct
Discontinued Application: 40469

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

Oct 25, 2002

40469 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40469
Product No.: 1

Product

Dosage Form: -
Strength: 750MG;7.5MG

Approval Date

Oct 25, 2002

Regulatory Status

Discontinued

2002
06 Nov
Discontinued Application: 40473

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Nov 06, 2002

40473 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40473
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Nov 06, 2002

Regulatory Status

Discontinued

2003
02 Jan
Discontinued Application: 40474

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Jan 02, 2003

40474 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40474
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Jan 02, 2003

Regulatory Status

Discontinued

2002
23 Oct
Discontinued Application: 40476

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

Oct 23, 2002

40476 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40476
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;10MG

Approval Date

Oct 23, 2002

Regulatory Status

Discontinued

2002
06 Nov
Discontinued Application: 40477

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Nov 06, 2002

40477 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40477
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Nov 06, 2002

Regulatory Status

Discontinued

2002
08 Nov
Discontinued Application: 40478

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Nov 08, 2002

40478 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40478
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Nov 08, 2002

Regulatory Status

Discontinued

2003
21 May
Discontinued Application: 40490

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

May 21, 2003

40490 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40490
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;7.5MG

Approval Date

May 21, 2003

Regulatory Status

Discontinued

2007
16 Aug
Discontinued Application: 40826

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

Aug 16, 2007

40826 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40826
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Aug 16, 2007

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90118

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Dec 23, 2008

90118 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90118
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90118

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Dec 23, 2008

90118 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90118
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90118

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

Dec 23, 2008

90118 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 90118
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Dec 23, 2008

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Dec 26, 2013

90535 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90535
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Dec 26, 2013

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

Dec 26, 2013

90535 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90535
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Dec 26, 2013

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Dec 26, 2013

90535 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90535
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Dec 26, 2013

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

Dec 26, 2013

90535 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 90535
Product No.: 4

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Dec 26, 2013

Regulatory Status

Discontinued

2001
11 Jul
Discontinued Application: 75838

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

Jul 11, 2001

75838 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 75838
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Jul 11, 2001

Regulatory Status

Discontinued

2005
16 Dec
Discontinued Application: 77184

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

Dec 16, 2005

77184 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identifiers

Application No.: 77184
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;37.5MG

Approval Date

Dec 16, 2005

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

18337 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18337
Product No.: 1

Product

Dosage Form: -
Strength: 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 201295

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

Dec 30, 2021

201295 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 201295
Product No.: 1

Product

Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML

Approval Date

Dec 30, 2021

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 201295

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG/15ML;10MG/15ML

Approval Date

Dec 30, 2021

201295 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 201295
Product No.: 2

Product

Dosage Form: -
Strength: 300MG/15ML;10MG/15ML

Approval Date

Dec 30, 2021

Regulatory Status

Discontinued

1982
03 May
Discontinued Application: 87757

Drug Name

CO-GESIC

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

May 03, 1982

87757 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 87757
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

May 03, 1982

Regulatory Status

Discontinued

1996
21 Nov
Discontinued Application: 40134

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

Nov 21, 1996

40134 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40134
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;7.5MG

Approval Date

Nov 21, 1996

Regulatory Status

Discontinued

1997
13 Aug
Discontinued Application: 40210

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Aug 13, 1997

40210 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40210
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Aug 13, 1997

Regulatory Status

Discontinued

1996
26 Jan
Discontinued Application: 40100

Drug Name

LORTAB

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

Jan 26, 1996

40100 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 40100
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;10MG

Approval Date

Jan 26, 1996

Regulatory Status

Discontinued

1982
09 Jul
Discontinued Application: 87722

Drug Name

LORTAB

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jul 09, 1982

87722 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 87722
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jul 09, 1982

Regulatory Status

Discontinued

2017
24 Mar
Discontinued Application: 206484

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Mar 24, 2017

206484 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206484
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Mar 24, 2017

Regulatory Status

Discontinued

2017
24 Mar
Discontinued Application: 206484

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Mar 24, 2017

206484 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206484
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Mar 24, 2017

Regulatory Status

Discontinued

2017
24 Mar
Discontinued Application: 206484

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

Mar 24, 2017

206484 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 206484
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Mar 24, 2017

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85896

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

Jan 01, 1982

85896 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85896
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86024

Drug Name

CAPITAL AND CODEINE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

86024 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 86024
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1985
19 Jun
Discontinued Application: 87811

Drug Name

PHRENILIN

Product Number

1

Dosage Form

-

Strength

325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jun 19, 1985

87811 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 87811
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

Jun 19, 1985

Regulatory Status

Discontinued

1985
19 Jun
Discontinued Application: 88831

Drug Name

PHRENILIN FORTE

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

Jun 19, 1985

88831 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 88831
Product No.: 1

Product

Dosage Form: -
Strength: 650MG;50MG

Approval Date

Jun 19, 1985

Regulatory Status

Discontinued

2001
22 Aug
Discontinued Application: 74911

Drug Name

PHRENILIN WITH CAFFEINE AND CODEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

Aug 22, 2001

74911 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Identifiers

Application No.: 74911
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG;30MG

Approval Date

Aug 22, 2001

Regulatory Status

Discontinued

2007
16 Mar
Discontinued Application: 77677

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Mar 16, 2007

77677 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 77677
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Mar 16, 2007

Regulatory Status

Discontinued

2007
16 Mar
Discontinued Application: 77677

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;100MG

Approval Date

Mar 16, 2007

77677 / 2

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Identifiers

Application No.: 77677
Product No.: 2

Product

Dosage Form: -
Strength: 650MG;100MG

Approval Date

Mar 16, 2007

Regulatory Status

Discontinued

2017
04 Aug
Discontinued Application: 206615

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

300MG;50MG;40MG

Approval Date

Aug 04, 2017

206615 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 206615
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;50MG;40MG

Approval Date

Aug 04, 2017

Regulatory Status

Discontinued

2014
26 Nov
Discontinued Application: 204785

Drug Name

TREZIX

Product Number

1

Dosage Form

-

Strength

320.5MG;30MG;16MG

Approval Date

Nov 26, 2014

204785 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 204785
Product No.: 1

Product

Dosage Form: -
Strength: 320.5MG;30MG;16MG

Approval Date

Nov 26, 2014

Regulatory Status

Discontinued

2018
23 Feb
Discontinued Application: 208653

Drug Name

APADAZ

Product Number

1

Dosage Form

-

Strength

325MG;EQ 6.12MG BASE

Approval Date

Feb 23, 2018

208653 / 1

Active Ingredient

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Identifiers

Application No.: 208653
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;EQ 6.12MG BASE

Approval Date

Feb 23, 2018

Regulatory Status

Discontinued

2019
04 Jan
Discontinued Application: 208653

Drug Name

APADAZ

Product Number

2

Dosage Form

-

Strength

325MG;EQ 4.08MG BASE

Approval Date

Jan 04, 2019

208653 / 2

Active Ingredient

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Identifiers

Application No.: 208653
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;EQ 4.08MG BASE

Approval Date

Jan 04, 2019

Regulatory Status

Discontinued

2019
04 Jan
Discontinued Application: 208653

Drug Name

APADAZ

Product Number

3

Dosage Form

-

Strength

325MG;EQ 8.16MG BASE

Approval Date

Jan 04, 2019

208653 / 3

Active Ingredient

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Identifiers

Application No.: 208653
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;EQ 8.16MG BASE

Approval Date

Jan 04, 2019

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86366

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

86366 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 86366
Product No.: 1

Product

Dosage Form: -
Strength: 120MG/5ML;12MG/5ML

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2025
17 Jan
Discontinued Application: 217241

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Jan 17, 2025

217241 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 217241
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Jan 17, 2025

Regulatory Status

Discontinued

2020
21 Sep
Discontinued Application: 203647

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Sep 21, 2020

203647 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 203647
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Sep 21, 2020

Regulatory Status

Discontinued

1986
04 Mar
Discontinued Application: 88584

Drug Name

DHC PLUS

Product Number

1

Dosage Form

-

Strength

356.4MG;30MG;16MG

Approval Date

Mar 04, 1986

88584 / 1

Active Ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Identifiers

Application No.: 88584
Product No.: 1

Product

Dosage Form: -
Strength: 356.4MG;30MG;16MG

Approval Date

Mar 04, 1986

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85685

Drug Name

PROVAL #3

Product Number

1

Dosage Form

-

Strength

325MG;30MG

Approval Date

Jan 01, 1982

85685 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Identifiers

Application No.: 85685
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;30MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16401

Drug Name

NEOPAP

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

Jan 01, 1982

16401 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 16401
Product No.: 1

Product

Dosage Form: -
Strength: 120MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 214928

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

Dec 30, 2021

214928 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 214928
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Dec 30, 2021

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 214928

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Dec 30, 2021

214928 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 214928
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Dec 30, 2021

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 214928

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

Dec 30, 2021

214928 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 214928
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Dec 30, 2021

Regulatory Status

Discontinued

1986
01 Oct
Discontinued Application: 87628

Drug Name

ANOQUAN

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Oct 01, 1986

87628 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 87628
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Oct 01, 1986

Regulatory Status

Discontinued

2015
30 Oct
Discontinued Application: 205120

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

Oct 30, 2015

205120 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 205120
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG

Approval Date

Oct 30, 2015

Regulatory Status

Discontinued

2017
05 Jun
Discontinued Application: 207635

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;50MG

Approval Date

Jun 05, 2017

207635 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Identifiers

Application No.: 207635
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;50MG

Approval Date

Jun 05, 2017

Regulatory Status

Discontinued

2017
10 Jan
Discontinued Application: 204984

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

Jan 10, 2017

204984 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Identifiers

Application No.: 204984
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;50MG;40MG

Approval Date

Jan 10, 2017

Regulatory Status

Discontinued

2018
08 Nov
Discontinued Application: 208540

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

Nov 08, 2018

208540 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 208540
Product No.: 1

Product

Dosage Form: -
Strength: 300MG;5MG

Approval Date

Nov 08, 2018

Regulatory Status

Discontinued

2018
08 Nov
Discontinued Application: 208540

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

Nov 08, 2018

208540 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 208540
Product No.: 2

Product

Dosage Form: -
Strength: 300MG;7.5MG

Approval Date

Nov 08, 2018

Regulatory Status

Discontinued

2018
08 Nov
Discontinued Application: 208540

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

Nov 08, 2018

208540 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 208540
Product No.: 3

Product

Dosage Form: -
Strength: 300MG;10MG

Approval Date

Nov 08, 2018

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

Oct 24, 2018

209958 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 209958
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;2.5MG

Approval Date

Oct 24, 2018

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

Oct 24, 2018

209958 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 209958
Product No.: 2

Product

Dosage Form: -
Strength: 325MG;5MG

Approval Date

Oct 24, 2018

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

Oct 24, 2018

209958 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 209958
Product No.: 3

Product

Dosage Form: -
Strength: 325MG;7.5MG

Approval Date

Oct 24, 2018

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

Oct 24, 2018

209958 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 209958
Product No.: 4

Product

Dosage Form: -
Strength: 325MG;10MG

Approval Date

Oct 24, 2018

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85910

Drug Name

OXYCODONE 2.5/APAP 500

Product Number

1

Dosage Form

-

Strength

500MG;2.5MG

Approval Date

Jan 01, 1982

85910 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 85910
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;2.5MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85911

Drug Name

OXYCODONE 5/APAP 500

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

Jan 01, 1982

85911 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Identifiers

Application No.: 85911
Product No.: 1

Product

Dosage Form: -
Strength: 500MG;5MG

Approval Date

Jan 01, 1982

Regulatory Status

Discontinued

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Related Databases
5 of 6 have records
EDQM CEP 20 KDMF 108 Japan DMF 10 NDC Database 193 FDA Approved Drugs Database 739
Drug Prices in Switzerland No records
Drug Status Breakdown
508 total
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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Record Details Preview

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Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Identifiers

Application No.: 85667
Product No.: 1

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