Novel Laboratories, Inc. Discontinued
FDA Approved Drugs

Novel Laboratories, Inc. Discontinued

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
  • Total Records 26
  • Latest Approval Date Jun 12, 2017
  • Data Source FDA
  • First Approval Date Feb 15, 1985
All
100
View
Unclassified
4
View
Discontinued
26
View
OTC
5
View
RX
65
View
Company Overview

Company

Novel Laboratories, Inc. Discontinued

Country

U.S.A

Website

Visit Website

Email

 info@novellabs.net

Social Profiles

Company Snapshot

Novel Laboratories, Inc. Discontinued

400 Campus Drive, Somerset, NJ 08873 

U.S.A

www.novellabs.net/  info@novellabs.net View on Map
FDA Approved Drug Records ( 26 records )
2011
20 Apr
Discontinued Application: 91528

Drug Name

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

Product Number

1

Dosage Form

-

Strength

1.5MG;5MG

Approval Date

2011-04-20

91528 / 1

Active Ingredient

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Application Number

91528

Product Number

1

Dosage Form

-

Strength

1.5MG;5MG

Approval Date

2011-04-20

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

2016-11-14

206142 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206142

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2016-11-14

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

2016-11-14

206142 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206142

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2016-11-14

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

2016-11-14

206142 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206142

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2016-11-14

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

2016-12-01

206245 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206245

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2016-12-01

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

2016-12-01

206245 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206245

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2016-12-01

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

2016-12-01

206245 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206245

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2016-12-01

Regulatory Status

Discontinued

2015
25 Feb
Discontinued Application: 204115

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-02-25

204115 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204115

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-02-25

Regulatory Status

Discontinued

2015
25 Feb
Discontinued Application: 204115

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-02-25

204115 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204115

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-02-25

Regulatory Status

Discontinued

2015
25 Feb
Discontinued Application: 204115

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-02-25

204115 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204115

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-02-25

Regulatory Status

Discontinued

2012
25 Jul
Discontinued Application: 91667

Drug Name

MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2012-07-25

91667 / 1

Active Ingredient

MISOPROSTOL

Application Number

91667

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2012-07-25

Regulatory Status

Discontinued

2012
25 Jul
Discontinued Application: 91667

Drug Name

MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2012-07-25

91667 / 2

Active Ingredient

MISOPROSTOL

Application Number

91667

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2012-07-25

Regulatory Status

Discontinued

2015
16 Dec
Discontinued Application: 203602

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2015-12-16

203602 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

203602

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2015-12-16

Regulatory Status

Discontinued

2015
16 Dec
Discontinued Application: 203602

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2015-12-16

203602 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

203602

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2015-12-16

Regulatory Status

Discontinued

2015
16 Dec
Discontinued Application: 203602

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2015-12-16

203602 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

203602

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2015-12-16

Regulatory Status

Discontinued

2015
16 Dec
Discontinued Application: 203602

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2015-12-16

203602 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

203602

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2015-12-16

Regulatory Status

Discontinued

2015
16 Dec
Discontinued Application: 203602

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2015-12-16

203602 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

203602

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2015-12-16

Regulatory Status

Discontinued

2017
12 Jun
Discontinued Application: 204021

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-06-12

204021 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204021

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2017
12 Jun
Discontinued Application: 204021

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

204021 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204021

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2017
12 Jun
Discontinued Application: 204021

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2017-06-12

204021 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204021

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2017
12 Jun
Discontinued Application: 204021

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2017-06-12

204021 / 4

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204021

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2017
12 Jun
Discontinued Application: 204021

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2017-06-12

204021 / 5

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204021

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2015
29 Apr
Discontinued Application: 204603

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2015-04-29

204603 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204603

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2015-04-29

Regulatory Status

Discontinued

2014
20 Aug
Discontinued Application: 202217

Drug Name

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

Product Number

1

Dosage Form

-

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Approval Date

2014-08-20

202217 / 1

Active Ingredient

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Application Number

202217

Product Number

1

Dosage Form

-

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Approval Date

2014-08-20

Regulatory Status

Discontinued

1985
15 Feb
Discontinued Application: 70022

Drug Name

SULFAMETHOPRIM

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1985-02-15

70022 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70022

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1985-02-15

Regulatory Status

Discontinued

1985
15 Feb
Discontinued Application: 70032

Drug Name

SULFAMETHOPRIM-DS

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1985-02-15

70032 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70032

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1985-02-15

Regulatory Status

Discontinued

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Drug Status Breakdown
26 total
  • Discontinued
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

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

Application Number

91528

Product Number

1

Active Ingredient

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Dosage Form

-

Strength

1.5MG;5MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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