Novel Laboratories, Inc.
FDA Approved Drugs

Novel Laboratories, Inc.

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.

RX Unclassified OTC Discontinued
  • Total Records 100
  • Latest Approval Date Aug 07, 2023
  • 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.

Country

U.S.A

Website

Visit Website

Email

 info@novellabs.net

Social Profiles

Company Snapshot

Novel Laboratories, Inc.

400 Campus Drive, Somerset, NJ 08873 

U.S.A

www.novellabs.net/  info@novellabs.net View on Map
FDA Approved Drug Records ( 100 records )
2015
30 Mar
RX Application: 202829

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2015-03-30

202829 / 1

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

202829

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2015-03-30

Regulatory Status

RX

2015
30 Mar
RX Application: 202829

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2015-03-30

202829 / 2

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

202829

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2015-03-30

Regulatory Status

RX

2015
30 Mar
RX Application: 202829

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2015-03-30

202829 / 3

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

202829

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2015-03-30

Regulatory Status

RX

2015
30 Mar
RX Application: 202829

Drug Name

AMLODIPINE BESYLATE AND VALSARTAN

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2015-03-30

202829 / 4

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

202829

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2015-03-30

Regulatory Status

RX

-
Unclassified Application: 202793

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

-

202793 / 1

Active Ingredient

AZITHROMYCIN

Application Number

202793

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202793

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

-

202793 / 2

Active Ingredient

AZITHROMYCIN

Application Number

202793

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

-

Regulatory Status

Unclassified

2017
20 Oct
RX Application: 204763

Drug Name

CARBIDOPA

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-10-20

204763 / 1

Active Ingredient

CARBIDOPA

Application Number

204763

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-10-20

Regulatory Status

RX

2016
30 Dec
RX Application: 204746

Drug Name

CEVIMELINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2016-12-30

204746 / 1

Active Ingredient

CEVIMELINE HYDROCHLORIDE

Application Number

204746

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2016-12-30

Regulatory Status

RX

2016
08 Mar
OTC Application: 206793

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-08

206793 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

206793

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-08

Regulatory Status

OTC

2016
08 Mar
OTC Application: 206793

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-03-08

206793 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

206793

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-03-08

Regulatory Status

OTC

2015
23 Nov
RX Application: 206075

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2015-11-23

206075 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

206075

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2015-11-23

Regulatory Status

RX

2018
04 May
RX Application: 208841

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-05-04

208841 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

208841

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-05-04

Regulatory Status

RX

2016
10 May
RX Application: 206792

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2016-05-10

206792 / 1

Active Ingredient

DESOXIMETASONE

Application Number

206792

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2016-05-10

Regulatory Status

RX

2015
04 Dec
RX Application: 204534

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-12-04

204534 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

204534

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2015-12-04

Regulatory Status

RX

2015
04 Dec
RX Application: 204534

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-12-04

204534 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

204534

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-12-04

Regulatory Status

RX

2015
04 Dec
RX Application: 204534

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-12-04

204534 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

204534

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-12-04

Regulatory Status

RX

2016
16 Mar
RX Application: 204330

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-16

204330 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

204330

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-16

Regulatory Status

RX

2016
16 Mar
RX Application: 204330

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-03-16

204330 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

204330

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-03-16

Regulatory Status

RX

2023
30 May
RX Application: 91076

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2023-05-30

91076 / 1

Active Ingredient

DIAZEPAM

Application Number

91076

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2023-05-30

Regulatory Status

RX

2023
30 May
RX Application: 91076

Drug Name

DIAZEPAM

Product Number

2

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2023-05-30

91076 / 2

Active Ingredient

DIAZEPAM

Application Number

91076

Product Number

2

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2023-05-30

Regulatory Status

RX

2015
09 Dec
RX Application: 205878

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2015-12-09

205878 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

205878

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2015-12-09

Regulatory Status

RX

2017
06 Sep
RX Application: 207558

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-09-06

207558 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

207558

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2017-09-06

Regulatory Status

RX

2012
17 Dec
RX Application: 201695

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2012-12-17

201695 / 1

Active Ingredient

FAMOTIDINE

Application Number

201695

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2012-12-17

Regulatory Status

RX

2017
07 Jul
RX Application: 204652

Drug Name

FLUCYTOSINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2017-07-07

204652 / 1

Active Ingredient

FLUCYTOSINE

Application Number

204652

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2017-07-07

Regulatory Status

RX

2017
07 Jul
RX Application: 204652

Drug Name

FLUCYTOSINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-07-07

204652 / 2

Active Ingredient

FLUCYTOSINE

Application Number

204652

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-07-07

Regulatory Status

RX

2023
31 Jul
RX Application: 207345

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2023-07-31

207345 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

207345

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2023-07-31

Regulatory Status

RX

2023
07 Aug
RX Application: 207347

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2023-08-07

207347 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

207347

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2023-08-07

Regulatory Status

RX

2017
21 Jul
RX Application: 206003

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-07-21

206003 / 1

Active Ingredient

FLUOCINONIDE

Application Number

206003

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-07-21

Regulatory Status

RX

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

2017
13 Feb
RX Application: 203535

Drug Name

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Product Number

1

Dosage Form

-

Strength

1.5MG/5ML;5MG/5ML

Approval Date

2017-02-13

203535 / 1

Active Ingredient

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Application Number

203535

Product Number

1

Dosage Form

-

Strength

1.5MG/5ML;5MG/5ML

Approval Date

2017-02-13

Regulatory Status

RX

2013
22 Feb
OTC Application: 202508

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2013-02-22

202508 / 1

Active Ingredient

LEVONORGESTREL

Application Number

202508

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2013-02-22

Regulatory Status

OTC

2016
22 Aug
RX Application: 207526

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-08-22

207526 / 1

Active Ingredient

LINEZOLID

Application Number

207526

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-08-22

Regulatory Status

RX

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

2015
14 Aug
RX Application: 204602

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2015-08-14

204602 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204602

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2015-08-14

Regulatory Status

RX

2015
14 Aug
RX Application: 204602

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2015-08-14

204602 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204602

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2015-08-14

Regulatory Status

RX

2015
13 Nov
RX Application: 207884

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-13

207884 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

207884

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-13

Regulatory Status

RX

2015
13 Nov
RX Application: 207884

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-11-13

207884 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

207884

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-11-13

Regulatory Status

RX

2015
13 Nov
RX Application: 207884

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2015-11-13

207884 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

207884

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2015-11-13

Regulatory Status

RX

2014
15 Aug
RX Application: 202191

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2014-08-15

202191 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

202191

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2014-08-15

Regulatory Status

RX

2014
15 Aug
RX Application: 202191

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-08-15

202191 / 2

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

202191

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2014-08-15

Regulatory Status

RX

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

2011
30 Dec
RX Application: 79247

Drug Name

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

0.398GM;1.102GM

Approval Date

2011-12-30

79247 / 1

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

79247

Product Number

1

Dosage Form

-

Strength

0.398GM;1.102GM

Approval Date

2011-12-30

Regulatory Status

RX

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

2014
08 Sep
RX Application: 201693

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2014-09-08

201693 / 1

Active Ingredient

NITROFURANTOIN

Application Number

201693

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2014-09-08

Regulatory Status

RX

2018
09 Jul
RX Application: 203233

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2018-07-09

203233 / 1

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

203233

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2018-07-09

Regulatory Status

RX

2018
09 Jul
RX Application: 203233

Drug Name

NITROFURANTOIN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2018-07-09

203233 / 2

Active Ingredient

NITROFURANTOIN, MACROCRYSTALLINE

Application Number

203233

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2018-07-09

Regulatory Status

RX

2017
24 Feb
RX Application: 204407

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2017-02-24

204407 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

204407

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2017-02-24

Regulatory Status

RX

2017
24 Feb
RX Application: 204407

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2017-02-24

204407 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

204407

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2017-02-24

Regulatory Status

RX

2017
24 Feb
RX Application: 204407

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2017-02-24

204407 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

204407

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2017-02-24

Regulatory Status

RX

2017
24 Feb
RX Application: 204407

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2017-02-24

204407 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

204407

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2017-02-24

Regulatory Status

RX

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

2015
24 Aug
RX Application: 204752

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-24

204752 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204752

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-24

Regulatory Status

RX

2009
01 Jun
RX Application: 90186

Drug Name

PEG 3350 AND ELECTROLYTES

Product Number

1

Dosage Form

-

Strength

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT

Approval Date

2009-06-01

90186 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

Application Number

90186

Product Number

1

Dosage Form

-

Strength

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT

Approval Date

2009-06-01

Regulatory Status

RX

2009
01 Jun
RX Application: 90231

Drug Name

PEG 3350 AND ELECTROLYTES

Product Number

1

Dosage Form

-

Strength

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

Approval Date

2009-06-01

90231 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

Application Number

90231

Product Number

1

Dosage Form

-

Strength

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

Approval Date

2009-06-01

Regulatory Status

RX

2009
27 May
RX Application: 90019

Drug Name

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

Product Number

1

Dosage Form

-

Strength

420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

Approval Date

2009-05-27

90019 / 1

Active Ingredient

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

Application Number

90019

Product Number

1

Dosage Form

-

Strength

420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

Approval Date

2009-05-27

Regulatory Status

RX

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

2012
25 Jan
RX Application: 90145

Drug Name

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

Product Number

1

Dosage Form

-

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date

2012-01-25

90145 / 1

Active Ingredient

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Application Number

90145

Product Number

1

Dosage Form

-

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date

2012-01-25

Regulatory Status

RX

2010
08 Dec
RX Application: 200181

Drug Name

PHENELZINE SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2010-12-08

200181 / 1

Active Ingredient

PHENELZINE SULFATE

Application Number

200181

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2010-12-08

Regulatory Status

RX

2009
06 Oct
OTC Application: 91077

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

91077 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

91077

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

Regulatory Status

OTC

2011
27 Jun
OTC Application: 91077

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2011-06-27

91077 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

91077

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2011-06-27

Regulatory Status

OTC

-
Unclassified Application: 90197

Drug Name

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

Product Number

1

Dosage Form

-

Strength

2MG; 5MG

Approval Date

-

90197 / 1

Active Ingredient

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

Application Number

90197

Product Number

1

Dosage Form

-

Strength

2MG; 5MG

Approval Date

-

Regulatory Status

Unclassified

2016
16 Aug
RX Application: 204828

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-08-16

204828 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

204828

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-08-16

Regulatory Status

RX

2016
16 Aug
RX Application: 204828

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-08-16

204828 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

204828

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-08-16

Regulatory Status

RX

2016
21 Jan
RX Application: 206347

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2016-01-21

206347 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

206347

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2016-01-21

Regulatory Status

RX

2016
21 Jan
RX Application: 206347

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

20MEQ

Approval Date

2016-01-21

206347 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

206347

Product Number

2

Dosage Form

-

Strength

20MEQ

Approval Date

2016-01-21

Regulatory Status

RX

2016
09 Aug
RX Application: 206759

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-08-09

206759 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

206759

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-08-09

Regulatory Status

RX

2016
09 Aug
RX Application: 206759

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-08-09

206759 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

206759

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-08-09

Regulatory Status

RX

2018
29 Aug
RX Application: 209786

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2018-08-29

209786 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209786

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2018-08-29

Regulatory Status

RX

2018
29 Aug
RX Application: 209786

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2018-08-29

209786 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

209786

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2018-08-29

Regulatory Status

RX

2018
21 Nov
RX Application: 210241

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2018-11-21

210241 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210241

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2018-11-21

Regulatory Status

RX

-
Unclassified Application: 202269

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

-

202269 / 1

Active Ingredient

PREGABALIN

Application Number

202269

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

-

Regulatory Status

Unclassified

2017
23 Feb
RX Application: 202511

Drug Name

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date

2017-02-23

202511 / 1

Active Ingredient

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Application Number

202511

Product Number

1

Dosage Form

-

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date

2017-02-23

Regulatory Status

RX

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

1987
21 Apr
RX Application: 71456

Drug Name

TEMAZEPAM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-04-21

71456 / 1

Active Ingredient

TEMAZEPAM

Application Number

71456

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-04-21

Regulatory Status

RX

1987
21 Apr
RX Application: 71457

Drug Name

TEMAZEPAM

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1987-04-21

71457 / 1

Active Ingredient

TEMAZEPAM

Application Number

71457

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1987-04-21

Regulatory Status

RX

2012
22 Jun
RX Application: 71457

Drug Name

TEMAZEPAM

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2012-06-22

71457 / 2

Active Ingredient

TEMAZEPAM

Application Number

71457

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2012-06-22

Regulatory Status

RX

2012
22 Jun
RX Application: 71457

Drug Name

TEMAZEPAM

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2012-06-22

71457 / 3

Active Ingredient

TEMAZEPAM

Application Number

71457

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2012-06-22

Regulatory Status

RX

2011
15 Jun
RX Application: 91437

Drug Name

TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-06-15

91437 / 1

Active Ingredient

TRIMETHOPRIM

Application Number

91437

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-06-15

Regulatory Status

RX

2016
31 May
RX Application: 206799

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2016-05-31

206799 / 1

Active Ingredient

VORICONAZOLE

Application Number

206799

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2016-05-31

Regulatory Status

RX

2015
03 Jun
RX Application: 204299

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

1.75MG

Approval Date

2015-06-03

204299 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

204299

Product Number

1

Dosage Form

-

Strength

1.75MG

Approval Date

2015-06-03

Regulatory Status

RX

2015
03 Jun
RX Application: 204299

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

3.5MG

Approval Date

2015-06-03

204299 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

204299

Product Number

2

Dosage Form

-

Strength

3.5MG

Approval Date

2015-06-03

Regulatory Status

RX

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Drug Status Breakdown
100 total
  • RX
  • Unclassified
  • OTC
  • 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

AMLODIPINE BESYLATE AND VALSARTAN

Application Number

202829

Product Number

1

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Dosage Form

-

Strength

EQ 5MG BASE;160MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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