Novast Laboratories
FDA Approved Drugs

Novast Laboratories

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
  • Total Records 94
  • Latest Approval Date Oct 28, 2025
  • Data Source FDA
  • First Approval Date Dec 29, 2010
All
94
View
Unclassified
14
View
OTC
1
View
RX
79
View
Company Overview

Company

Novast Laboratories

Country

China

Website

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Company Snapshot

Novast Laboratories

1692 Xinghu Road, Suite A-3, Bldg 21, Jiangsu Prov.,, Nantong, Jiangsu 226009

China

www.novastlabs.com/ View on Map
FDA Approved Drug Records ( 94 records )
2016
30 Sep
RX Application: 203434

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-09-30

203434 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

203434

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-09-30

Regulatory Status

RX

2020
15 Apr
RX Application: 202962

Drug Name

CHABELINA FE

Product Number

1

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Approval Date

2020-04-15

202962 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202962

Product Number

1

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Approval Date

2020-04-15

Regulatory Status

RX

2019
05 Mar
RX Application: 209675

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2019-03-05

209675 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

209675

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2019-03-05

Regulatory Status

RX

2025
15 Oct
RX Application: 214023

Drug Name

CONJUGATED ESTROGENS

Product Number

1

Dosage Form

-

Strength

0.9MG

Approval Date

2025-10-15

214023 / 1

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

214023

Product Number

1

Dosage Form

-

Strength

0.9MG

Approval Date

2025-10-15

Regulatory Status

RX

2025
15 Oct
RX Application: 214023

Drug Name

CONJUGATED ESTROGENS

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

2025-10-15

214023 / 2

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

214023

Product Number

2

Dosage Form

-

Strength

1.25MG

Approval Date

2025-10-15

Regulatory Status

RX

2025
15 Oct
RX Application: 214025

Drug Name

CONJUGATED ESTROGENS

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2025-10-15

214025 / 1

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

214025

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2025-10-15

Regulatory Status

RX

2025
15 Oct
RX Application: 214025

Drug Name

CONJUGATED ESTROGENS

Product Number

2

Dosage Form

-

Strength

0.45MG

Approval Date

2025-10-15

214025 / 2

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

214025

Product Number

2

Dosage Form

-

Strength

0.45MG

Approval Date

2025-10-15

Regulatory Status

RX

2025
15 Oct
RX Application: 214025

Drug Name

CONJUGATED ESTROGENS

Product Number

3

Dosage Form

-

Strength

0.625MG

Approval Date

2025-10-15

214025 / 3

Active Ingredient

ESTROGENS, CONJUGATED

Application Number

214025

Product Number

3

Dosage Form

-

Strength

0.625MG

Approval Date

2025-10-15

Regulatory Status

RX

2024
27 Aug
RX Application: 214732

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2024-08-27

214732 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

214732

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2024-08-27

Regulatory Status

RX

2024
27 Aug
RX Application: 214732

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2024-08-27

214732 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

214732

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2024-08-27

Regulatory Status

RX

2011
22 Dec
RX Application: 90948

Drug Name

DASETTA 1/35

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2011-12-22

90948 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

90948

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2011-12-22

Regulatory Status

RX

2011
22 Dec
RX Application: 90946

Drug Name

DASETTA 7/7/7

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

2011-12-22

90946 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

90946

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

2011-12-22

Regulatory Status

RX

2019
06 Jun
RX Application: 208357

Drug Name

DESMOPRESSIN ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2019-06-06

208357 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

208357

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2019-06-06

Regulatory Status

RX

2019
06 Jun
RX Application: 208357

Drug Name

DESMOPRESSIN ACETATE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2019-06-06

208357 / 2

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

208357

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2019-06-06

Regulatory Status

RX

2013
12 Jul
RX Application: 91234

Drug Name

DESOGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG

Approval Date

2013-07-12

91234 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

91234

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG

Approval Date

2013-07-12

Regulatory Status

RX

2019
14 Jun
RX Application: 208783

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2019-06-14

208783 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

208783

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2019-06-14

Regulatory Status

RX

2019
14 Jun
RX Application: 208783

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2019-06-14

208783 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

208783

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2019-06-14

Regulatory Status

RX

2019
14 Jun
RX Application: 208783

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2019-06-14

208783 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

208783

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2019-06-14

Regulatory Status

RX

2019
14 Jun
RX Application: 208783

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2019-06-14

208783 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

208783

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2019-06-14

Regulatory Status

RX

2019
14 Jun
RX Application: 208783

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2019-06-14

208783 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

208783

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2019-06-14

Regulatory Status

RX

2025
02 Jul
RX Application: 218032

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-07-02

218032 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

218032

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-07-02

Regulatory Status

RX

2025
02 Jul
RX Application: 218032

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2025-07-02

218032 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

218032

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2025-07-02

Regulatory Status

RX

2025
02 Jul
RX Application: 218032

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2025-07-02

218032 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

218032

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2025-07-02

Regulatory Status

RX

2020
22 Oct
RX Application: 91692

Drug Name

DOLISHALE

Product Number

1

Dosage Form

-

Strength

0.02MG;0.09MG

Approval Date

2020-10-22

91692 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

91692

Product Number

1

Dosage Form

-

Strength

0.02MG;0.09MG

Approval Date

2020-10-22

Regulatory Status

RX

2025
28 Oct
RX Application: 218031

Drug Name

DROSPIRENONE AND ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.5MG;1MG

Approval Date

2025-10-28

218031 / 1

Active Ingredient

DROSPIRENONE; ESTRADIOL

Application Number

218031

Product Number

1

Dosage Form

-

Strength

0.5MG;1MG

Approval Date

2025-10-28

Regulatory Status

RX

2012
28 Mar
RX Application: 91105

Drug Name

ELINEST

Product Number

1

Dosage Form

-

Strength

0.03MG;0.3MG

Approval Date

2012-03-28

91105 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTREL

Application Number

91105

Product Number

1

Dosage Form

-

Strength

0.03MG;0.3MG

Approval Date

2012-03-28

Regulatory Status

RX

2019
03 Apr
RX Application: 210612

Drug Name

ESTRADIOL AND NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.5MG;0.1MG

Approval Date

2019-04-03

210612 / 1

Active Ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Application Number

210612

Product Number

1

Dosage Form

-

Strength

0.5MG;0.1MG

Approval Date

2019-04-03

Regulatory Status

RX

2019
03 Apr
RX Application: 210612

Drug Name

ESTRADIOL AND NORETHINDRONE ACETATE

Product Number

2

Dosage Form

-

Strength

1MG;0.5MG

Approval Date

2019-04-03

210612 / 2

Active Ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Application Number

210612

Product Number

2

Dosage Form

-

Strength

1MG;0.5MG

Approval Date

2019-04-03

Regulatory Status

RX

-
Unclassified Application: 91690

Drug Name

ETHINYL ESTRADIOL AND LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG; 0.15MG,N/A

Approval Date

-

91690 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

91690

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG; 0.15MG,N/A

Approval Date

-

Regulatory Status

Unclassified

2012
28 Mar
RX Application: 90721

Drug Name

FALMINA

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2012-03-28

90721 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

90721

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2012-03-28

Regulatory Status

RX

2016
11 Mar
OTC Application: 207976

Drug Name

HER STYLE

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2016-03-11

207976 / 1

Active Ingredient

LEVONORGESTREL

Application Number

207976

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2016-03-11

Regulatory Status

OTC

2017
08 May
RX Application: 204853

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2017-05-08

204853 / 1

Active Ingredient

INDOMETHACIN

Application Number

204853

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2017-05-08

Regulatory Status

RX

2014
20 Mar
RX Application: 202996

Drug Name

LARIN 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2014-03-20

202996 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202996

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2014-03-20

Regulatory Status

RX

2013
04 Dec
RX Application: 202995

Drug Name

LARIN 1/20

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-12-04

202995 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202995

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-12-04

Regulatory Status

RX

2015
18 Feb
RX Application: 202994

Drug Name

LARIN 24 FE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2015-02-18

202994 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202994

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2015-02-18

Regulatory Status

RX

2013
23 Aug
RX Application: 91453

Drug Name

LARIN FE 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2013-08-23

91453 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

91453

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2013-08-23

Regulatory Status

RX

2013
26 Aug
RX Application: 91454

Drug Name

LARIN FE 1/20

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-08-26

91454 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

91454

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-08-26

Regulatory Status

RX

2016
03 Jun
RX Application: 203435

Drug Name

LERIBANE

Product Number

1

Dosage Form

-

Strength

0.005MG;1MG

Approval Date

2016-06-03

203435 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

203435

Product Number

1

Dosage Form

-

Strength

0.005MG;1MG

Approval Date

2016-06-03

Regulatory Status

RX

2016
03 Jun
RX Application: 203435

Drug Name

LERIBANE

Product Number

2

Dosage Form

-

Strength

0.0025MG;0.5MG

Approval Date

2016-06-03

203435 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

203435

Product Number

2

Dosage Form

-

Strength

0.0025MG;0.5MG

Approval Date

2016-06-03

Regulatory Status

RX

2010
29 Dec
RX Application: 90719

Drug Name

LEVONEST

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Approval Date

2010-12-29

90719 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

90719

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Approval Date

2010-12-29

Regulatory Status

RX

-
Unclassified Application: 208661

Drug Name

LO LARIN FE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

-

208661 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

208661

Product Number

1

Dosage Form

-

Strength

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

Approval Date

-

Regulatory Status

Unclassified

2019
11 Feb
RX Application: 209548

Drug Name

LO-MALMOREDE

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2019-02-11

209548 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Application Number

209548

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2019-02-11

Regulatory Status

RX

2018
25 Jul
RX Application: 209547

Drug Name

MALMOREDE

Product Number

1

Dosage Form

-

Strength

0.05MG;1MG

Approval Date

2018-07-25

209547 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Application Number

209547

Product Number

1

Dosage Form

-

Strength

0.05MG;1MG

Approval Date

2018-07-25

Regulatory Status

RX

2016
26 Jan
RX Application: 202016

Drug Name

MELAMISA

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2016-01-26

202016 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

202016

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2016-01-26

Regulatory Status

RX

-
Unclassified Application: 214731

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

-

214731 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

214731

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214731

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

-

214731 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

214731

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214731

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

-

214731 / 3

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

214731

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214731

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

-

214731 / 4

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

214731

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

-

Regulatory Status

Unclassified

2024
22 Aug
RX Application: 218410

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2024-08-22

218410 / 1

Active Ingredient

MESALAMINE

Application Number

218410

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2024-08-22

Regulatory Status

RX

2018
02 Nov
RX Application: 209674

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-11-02

209674 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

209674

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-11-02

Regulatory Status

RX

2018
02 Nov
RX Application: 209674

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2018-11-02

209674 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

209674

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2018-11-02

Regulatory Status

RX

2018
06 Feb
RX Application: 204106

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2018-02-06

204106 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

204106

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2018-02-06

Regulatory Status

RX

2018
06 Feb
RX Application: 204106

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2018-02-06

204106 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

204106

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2018-02-06

Regulatory Status

RX

2018
06 Feb
RX Application: 204106

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2018-02-06

204106 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

204106

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2018-02-06

Regulatory Status

RX

2018
06 Feb
RX Application: 204106

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2018-02-06

204106 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

204106

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2018-02-06

Regulatory Status

RX

2012
23 May
RX Application: 90523

Drug Name

MONO-LINYAH

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2012-05-23

90523 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

90523

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2012-05-23

Regulatory Status

RX

2016
25 Aug
RX Application: 202987

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2016-08-25

202987 / 1

Active Ingredient

NIFEDIPINE

Application Number

202987

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2016-08-25

Regulatory Status

RX

2016
25 Aug
RX Application: 202987

Drug Name

NIFEDIPINE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2016-08-25

202987 / 2

Active Ingredient

NIFEDIPINE

Application Number

202987

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2016-08-25

Regulatory Status

RX

2016
25 Aug
RX Application: 202987

Drug Name

NIFEDIPINE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2016-08-25

202987 / 3

Active Ingredient

NIFEDIPINE

Application Number

202987

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2016-08-25

Regulatory Status

RX

2019
12 Mar
RX Application: 210614

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2019-03-12

210614 / 1

Active Ingredient

NIFEDIPINE

Application Number

210614

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2019-03-12

Regulatory Status

RX

2019
12 Mar
RX Application: 210614

Drug Name

NIFEDIPINE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2019-03-12

210614 / 2

Active Ingredient

NIFEDIPINE

Application Number

210614

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2019-03-12

Regulatory Status

RX

2019
12 Mar
RX Application: 210614

Drug Name

NIFEDIPINE

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2019-03-12

210614 / 3

Active Ingredient

NIFEDIPINE

Application Number

210614

Product Number

3

Dosage Form

-

Strength

90MG

Approval Date

2019-03-12

Regulatory Status

RX

2013
13 Sep
RX Application: 200961

Drug Name

NORETHINDRONE

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-09-13

200961 / 1

Active Ingredient

NORETHINDRONE

Application Number

200961

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-09-13

Regulatory Status

RX

2013
13 Sep
RX Application: 202014

Drug Name

NORETHINDRONE

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-09-13

202014 / 1

Active Ingredient

NORETHINDRONE

Application Number

202014

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-09-13

Regulatory Status

RX

-
Unclassified Application: 218724

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

218724 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

218724

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218724

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

-

218724 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

218724

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

-

Regulatory Status

Unclassified

2019
30 Oct
RX Application: 210611

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-10-30

210611 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

210611

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-10-30

Regulatory Status

RX

2011
22 Dec
RX Application: 90947

Drug Name

PHILITH

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2011-12-22

90947 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

90947

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2011-12-22

Regulatory Status

RX

2013
01 Aug
RX Application: 91247

Drug Name

PIMTREA

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG

Approval Date

2013-08-01

91247 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

91247

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG

Approval Date

2013-08-01

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

2022-02-03

213444 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

2022-02-03

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2022-02-03

213444 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2022-02-03

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2022-02-03

213444 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2022-02-03

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

2.25MG

Approval Date

2022-02-03

213444 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

4

Dosage Form

-

Strength

2.25MG

Approval Date

2022-02-03

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2022-02-03

213444 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2022-02-03

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

3.75MG

Approval Date

2022-02-03

213444 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

6

Dosage Form

-

Strength

3.75MG

Approval Date

2022-02-03

Regulatory Status

RX

2022
03 Feb
RX Application: 213444

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

4.5MG

Approval Date

2022-02-03

213444 / 7

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

213444

Product Number

7

Dosage Form

-

Strength

4.5MG

Approval Date

2022-02-03

Regulatory Status

RX

2017
29 Nov
RX Application: 208947

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2017-11-29

208947 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208947

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 208947

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2017-11-29

208947 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208947

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 208947

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-11-29

208947 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208947

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 208947

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2017-11-29

208947 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208947

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2017
29 Nov
RX Application: 208947

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2017-11-29

208947 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

208947

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2017-11-29

Regulatory Status

RX

2023
27 Sep
RX Application: 210668

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-09-27

210668 / 1

Active Ingredient

RANOLAZINE

Application Number

210668

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2023-09-27

Regulatory Status

RX

2023
27 Sep
RX Application: 210668

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-09-27

210668 / 2

Active Ingredient

RANOLAZINE

Application Number

210668

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2023-09-27

Regulatory Status

RX

2014
15 Sep
RX Application: 90716

Drug Name

SETLAKIN

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2014-09-15

90716 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

90716

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2014-09-15

Regulatory Status

RX

-
Unclassified Application: 218069

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE TABLET

Approval Date

-

218069 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

218069

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE TABLET

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218069

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

218069 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

218069

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218069

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

-

218069 / 4

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

218069

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218069

Drug Name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1000MG

Approval Date

-

218069 / 5

Active Ingredient

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Application Number

218069

Product Number

5

Dosage Form

-

Strength

1000MG

Approval Date

-

Regulatory Status

Unclassified

2012
30 May
RX Application: 90524

Drug Name

TRI-LINYAH

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Approval Date

2012-05-30

90524 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

90524

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Approval Date

2012-05-30

Regulatory Status

RX

2022
02 Sep
RX Application: 90541

Drug Name

TRI-LO-LINYAH

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2022-09-02

90541 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

90541

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2022-09-02

Regulatory Status

RX

-
Unclassified Application: 90541

Drug Name

TRI-LO-LINYAH

Product Number

2

Dosage Form

-

Strength

0.215MG; 0.025MG

Approval Date

-

90541 / 2

Active Ingredient

NORGESTIMATE; ETHINYL ESTRADIOL

Application Number

90541

Product Number

2

Dosage Form

-

Strength

0.215MG; 0.025MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 90541

Drug Name

TRI-LO-LINYAH

Product Number

3

Dosage Form

-

Strength

0.25MG; 0.025MG

Approval Date

-

90541 / 3

Active Ingredient

NORGESTIMATE; ETHINYL ESTRADIOL

Application Number

90541

Product Number

3

Dosage Form

-

Strength

0.25MG; 0.025MG

Approval Date

-

Regulatory Status

Unclassified

2012
27 Mar
RX Application: 91204

Drug Name

WERA

Product Number

1

Dosage Form

-

Strength

0.035MG;0.5MG

Approval Date

2012-03-27

91204 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

91204

Product Number

1

Dosage Form

-

Strength

0.035MG;0.5MG

Approval Date

2012-03-27

Regulatory Status

RX

2014
19 Nov
RX Application: 202015

Drug Name

YAELA

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2014-11-19

202015 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

202015

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2014-11-19

Regulatory Status

RX

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Drug Status Breakdown
94 total
  • RX
  • Unclassified
  • OTC
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

ACETAZOLAMIDE

Application Number

203434

Product Number

1

Active Ingredient

ACETAZOLAMIDE

Dosage Form

-

Strength

500MG

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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