APIL
FDA Approved Drugs

APIL

FDA Approved Drugs Database

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

Discontinued RX
  • Total Records 30
  • Latest Approval Date Jul 07, 2014
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
30
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Discontinued
25
View
RX
5
View
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FDA Approved Drug Records ( 30 records )
1998
27 Mar
Discontinued Application: 20835

Drug Name

ACTONEL

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1998-03-27

20835 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

20835

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1998-03-27

Regulatory Status

Discontinued

2000
14 Apr
Discontinued Application: 20835

Drug Name

ACTONEL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-04-14

20835 / 2

Active Ingredient

RISEDRONATE SODIUM

Application Number

20835

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-04-14

Regulatory Status

Discontinued

2002
25 May
RX Application: 20835

Drug Name

ACTONEL

Product Number

3

Dosage Form

-

Strength

35MG

Approval Date

2002-05-25

20835 / 3

Active Ingredient

RISEDRONATE SODIUM

Application Number

20835

Product Number

3

Dosage Form

-

Strength

35MG

Approval Date

2002-05-25

Regulatory Status

RX

2007
16 Apr
Discontinued Application: 20835

Drug Name

ACTONEL

Product Number

4

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-04-16

20835 / 4

Active Ingredient

RISEDRONATE SODIUM

Application Number

20835

Product Number

4

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-04-16

Regulatory Status

Discontinued

2008
22 Apr
RX Application: 20835

Drug Name

ACTONEL

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2008-04-22

20835 / 5

Active Ingredient

RISEDRONATE SODIUM

Application Number

20835

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2008-04-22

Regulatory Status

RX

1992
31 Jan
Discontinued Application: 19651

Drug Name

ASACOL

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1992-01-31

19651 / 1

Active Ingredient

MESALAMINE

Application Number

19651

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1992-01-31

Regulatory Status

Discontinued

2010
08 Oct
RX Application: 22560

Drug Name

ATELVIA

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2010-10-08

22560 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

22560

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2010-10-08

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17831

Drug Name

DIDRONEL

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17831 / 1

Active Ingredient

ETIDRONATE DISODIUM

Application Number

17831

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17831

Drug Name

DIDRONEL

Product Number

2

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17831 / 2

Active Ingredient

ETIDRONATE DISODIUM

Application Number

17831

Product Number

2

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
09 Oct
Discontinued Application: 20130

Drug Name

ESTROSTEP 21

Product Number

1

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-09

20130 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

20130

Product Number

1

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-09

Regulatory Status

Discontinued

1996
09 Oct
Discontinued Application: 20130

Drug Name

ESTROSTEP FE

Product Number

2

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-09

20130 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

20130

Product Number

2

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-10-09

Regulatory Status

Discontinued

2003
14 Nov
Discontinued Application: 21490

Drug Name

FEMCON FE

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-11-14

21490 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

21490

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-11-14

Regulatory Status

Discontinued

2005
14 Jan
Discontinued Application: 21065

Drug Name

FEMHRT

Product Number

1

Dosage Form

-

Strength

0.0025MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-01-14

21065 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

21065

Product Number

1

Dosage Form

-

Strength

0.0025MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-01-14

Regulatory Status

Discontinued

1999
15 Oct
Discontinued Application: 21065

Drug Name

FEMHRT

Product Number

2

Dosage Form

-

Strength

0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-10-15

21065 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

21065

Product Number

2

Dosage Form

-

Strength

0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-10-15

Regulatory Status

Discontinued

2004
20 Aug
Discontinued Application: 21633

Drug Name

FEMTRACE

Product Number

1

Dosage Form

-

Strength

0.45MG

Approval Date

2004-08-20

21633 / 1

Active Ingredient

ESTRADIOL ACETATE

Application Number

21633

Product Number

1

Dosage Form

-

Strength

0.45MG

Approval Date

2004-08-20

Regulatory Status

Discontinued

2004
20 Aug
Discontinued Application: 21633

Drug Name

FEMTRACE

Product Number

2

Dosage Form

-

Strength

0.9MG

Approval Date

2004-08-20

21633 / 2

Active Ingredient

ESTRADIOL ACETATE

Application Number

21633

Product Number

2

Dosage Form

-

Strength

0.9MG

Approval Date

2004-08-20

Regulatory Status

Discontinued

2004
20 Aug
Discontinued Application: 21633

Drug Name

FEMTRACE

Product Number

3

Dosage Form

-

Strength

1.8MG

Approval Date

2004-08-20

21633 / 3

Active Ingredient

ESTRADIOL ACETATE

Application Number

21633

Product Number

3

Dosage Form

-

Strength

1.8MG

Approval Date

2004-08-20

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

1997-02-14

40148 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40148

Product Number

2

Dosage Form

-

Strength

500MG;10MG

Approval Date

1997-02-14

Regulatory Status

Discontinued

2010
21 Oct
RX Application: 22501

Drug Name

LO LOESTRIN FE

Product Number

1

Dosage Form

-

Strength

0.01MG,0.01MG;1MG,N/A

Approval Date

2010-10-21

22501 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

22501

Product Number

1

Dosage Form

-

Strength

0.01MG,0.01MG;1MG,N/A

Approval Date

2010-10-21

Regulatory Status

RX

2013
24 Jul
Discontinued Application: 204654

Drug Name

LO MINASTRIN FE

Product Number

1

Dosage Form

-

Strength

0.01MG,0.01MG,N/A;1MG,N/A,N/A

Approval Date

2013-07-24

204654 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

204654

Product Number

1

Dosage Form

-

Strength

0.01MG,0.01MG,N/A;1MG,N/A,N/A

Approval Date

2013-07-24

Regulatory Status

Discontinued

2013
08 May
Discontinued Application: 203667

Drug Name

MINASTRIN 24 FE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-05-08

203667 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

203667

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-05-08

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 40099

Drug Name

NORCO

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

1997-06-25

40099 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40099

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

1997-06-25

Regulatory Status

Discontinued

1997
14 Feb
Discontinued Application: 40148

Drug Name

NORCO

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

1997-02-14

40148 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40148

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

1997-02-14

Regulatory Status

Discontinued

2000
12 Sep
Discontinued Application: 40148

Drug Name

NORCO

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2000-09-12

40148 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40148

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2000-09-12

Regulatory Status

Discontinued

2014
07 Jul
Discontinued Application: 40148

Drug Name

NORCO

Product Number

4

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2014-07-07

40148 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40148

Product Number

4

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2014-07-07

Regulatory Status

Discontinued

2014
07 Jul
Discontinued Application: 40148

Drug Name

NORCO

Product Number

5

Dosage Form

-

Strength

325MG;5MG

Approval Date

2014-07-07

40148 / 5

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40148

Product Number

5

Dosage Form

-

Strength

325MG;5MG

Approval Date

2014-07-07

Regulatory Status

Discontinued

2006
19 May
Discontinued Application: 21860

Drug Name

SARAFEM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-05-19

21860 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

21860

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-05-19

Regulatory Status

Discontinued

2006
19 May
Discontinued Application: 21860

Drug Name

SARAFEM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2006-05-19

21860 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

21860

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2006-05-19

Regulatory Status

Discontinued

2006
19 May
Discontinued Application: 21860

Drug Name

SARAFEM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-05-19

21860 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

21860

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-05-19

Regulatory Status

Discontinued

2013
19 Apr
RX Application: 204426

Drug Name

TAYTULLA

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-04-19

204426 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

204426

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-04-19

Regulatory Status

RX

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Drug Status Breakdown
30 total
  • Discontinued
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ACTONEL

Application Number

20835

Product Number

1

Active Ingredient

RISEDRONATE SODIUM

Dosage Form

-

Strength

30MG

FDA Approved Drug Data

Approved drug product information

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