Strides Pharma Science
FDA Approved Drugs

Strides Pharma Science

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 Discontinued Unclassified OTC
  • Total Records 227
  • Latest Approval Date Mar 23, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
227
View
Unclassified
1
View
Discontinued
103
View
OTC
6
View
RX
117
View
Company Overview

Company

Strides Pharma Science

Country

India

Website

Visit Website

Email

enquiries@synergice.co

Social Profiles

LinkedIn
Company Snapshot

Strides Pharma Science

Strides House, Bilekahalli, Bannerghatta Road, Bangalore – 560076

India

www.synergice.co/ enquiries@synergice.co View on Map
FDA Approved Drug Records ( 227 records )
2011
27 Jul
RX Application: 90912

Drug Name

ACARBOSE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-07-27

90912 / 1

Active Ingredient

ACARBOSE

Application Number

90912

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-07-27

Regulatory Status

RX

2011
27 Jul
RX Application: 90912

Drug Name

ACARBOSE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2011-07-27

90912 / 2

Active Ingredient

ACARBOSE

Application Number

90912

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2011-07-27

Regulatory Status

RX

2011
27 Jul
RX Application: 90912

Drug Name

ACARBOSE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2011-07-27

90912 / 3

Active Ingredient

ACARBOSE

Application Number

90912

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2011-07-27

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 86366

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

1982-01-01

86366 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

86366

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2025
17 Jan
Discontinued Application: 217241

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2025-01-17

217241 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

217241

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2025-01-17

Regulatory Status

Discontinued

2017
20 Nov
RX Application: 209734

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2017-11-20

209734 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

209734

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2017-11-20

Regulatory Status

RX

2017
20 Nov
RX Application: 209734

Drug Name

ACETAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2017-11-20

209734 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

209734

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2017-11-20

Regulatory Status

RX

2018
07 Dec
Discontinued Application: 210011

Drug Name

ALBENDAZOLE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-12-07

210011 / 1

Active Ingredient

ALBENDAZOLE

Application Number

210011

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-12-07

Regulatory Status

Discontinued

2017
09 Jun
RX Application: 209035

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-06-09

209035 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

209035

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-06-09

Regulatory Status

RX

2017
07 Jun
RX Application: 209047

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-06-07

209047 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

209047

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-06-07

Regulatory Status

RX

2007
11 Jul
Discontinued Application: 77516

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-11

77516 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77516

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-11

Regulatory Status

Discontinued

2007
11 Jul
Discontinued Application: 77516

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-11

77516 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77516

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-11

Regulatory Status

Discontinued

2007
11 Jul
Discontinued Application: 77516

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-11

77516 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77516

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-11

Regulatory Status

Discontinued

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-02-18

79021 / 1

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 18MG BASE

Approval Date

2021-02-18

79021 / 2

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

2

Dosage Form

-

Strength

EQ 18MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-02-18

79021 / 3

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-02-18

79021 / 4

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2021-02-18

79021 / 5

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

5

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2021-02-18

79021 / 6

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

6

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 79021

Drug Name

ATOMOXETINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2021-02-18

79021 / 7

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

79021

Product Number

7

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2021-02-18

Regulatory Status

RX

2023
21 Dec
Discontinued Application: 217634

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-12-21

217634 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217634

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-12-21

Regulatory Status

Discontinued

2023
21 Dec
Discontinued Application: 217634

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-12-21

217634 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217634

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-12-21

Regulatory Status

Discontinued

2023
21 Dec
Discontinued Application: 217634

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-12-21

217634 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217634

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-12-21

Regulatory Status

Discontinued

2023
21 Dec
Discontinued Application: 217634

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2023-12-21

217634 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

217634

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2023-12-21

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 215772

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2022-07-15

215772 / 1

Active Ingredient

AZITHROMYCIN

Application Number

215772

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
12 Jul
Discontinued Application: 215773

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2022-07-12

215773 / 1

Active Ingredient

AZITHROMYCIN

Application Number

215773

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2022-07-12

Regulatory Status

Discontinued

2014
25 Aug
RX Application: 202330

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-08-25

202330 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

202330

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 202330

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-08-25

202330 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

202330

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 202330

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-08-25

202330 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

202330

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 202330

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2014-08-25

202330 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

202330

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2014-08-25

Regulatory Status

RX

2017
17 Feb
RX Application: 202330

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

7.5MG

Approval Date

2017-02-17

202330 / 5

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

202330

Product Number

5

Dosage Form

-

Strength

7.5MG

Approval Date

2017-02-17

Regulatory Status

RX

2020
21 Sep
Discontinued Application: 203647

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2020-09-21

203647 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

203647

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2020-09-21

Regulatory Status

Discontinued

2016
22 Sep
Discontinued Application: 204195

Drug Name

BUTALBITAL, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2016-09-22

204195 / 1

Active Ingredient

ASPIRIN; BUTALBITAL; CAFFEINE

Application Number

204195

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2016-09-22

Regulatory Status

Discontinued

2015
12 Nov
Discontinued Application: 205513

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2015-11-12

205513 / 1

Active Ingredient

CARISOPRODOL

Application Number

205513

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2015-11-12

Regulatory Status

Discontinued

2015
12 Nov
Discontinued Application: 205513

Drug Name

CARISOPRODOL

Product Number

2

Dosage Form

-

Strength

350MG

Approval Date

2015-11-12

205513 / 2

Active Ingredient

CARISOPRODOL

Application Number

205513

Product Number

2

Dosage Form

-

Strength

350MG

Approval Date

2015-11-12

Regulatory Status

Discontinued

2025
29 Apr
Discontinued Application: 213127

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-04-29

213127 / 1

Active Ingredient

CELECOXIB

Application Number

213127

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-04-29

Regulatory Status

Discontinued

2025
29 Apr
Discontinued Application: 213127

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-04-29

213127 / 2

Active Ingredient

CELECOXIB

Application Number

213127

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-04-29

Regulatory Status

Discontinued

2025
29 Apr
Discontinued Application: 213127

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2025-04-29

213127 / 3

Active Ingredient

CELECOXIB

Application Number

213127

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2025-04-29

Regulatory Status

Discontinued

2018
30 Apr
RX Application: 209226

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-04-30

209226 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

209226

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209226

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-04-30

209226 / 2

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

209226

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209226

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2018-04-30

209226 / 3

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

209226

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2018-04-30

Regulatory Status

RX

2022
10 Mar
RX Application: 209173

Drug Name

COLCHICINE

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2022-03-10

209173 / 1

Active Ingredient

COLCHICINE

Application Number

209173

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2022-03-10

Regulatory Status

RX

2019
21 Jun
Discontinued Application: 205077

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-06-21

205077 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

205077

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-06-21

Regulatory Status

Discontinued

2019
21 Jun
Discontinued Application: 205077

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-06-21

205077 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

205077

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-06-21

Regulatory Status

Discontinued

2019
21 Jun
Discontinued Application: 205077

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-06-21

205077 / 3

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

205077

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-06-21

Regulatory Status

Discontinued

-
Unclassified Application: 217016

Drug Name

DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

50MG/300MG/300MG

Approval Date

-

217016 / 1

Active Ingredient

DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

Application Number

217016

Product Number

1

Dosage Form

-

Strength

50MG/300MG/300MG

Approval Date

-

Regulatory Status

Unclassified

2011
31 May
Discontinued Application: 78662

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

78662 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

78662

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 78662

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

78662 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

78662

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2012
08 Jun
Discontinued Application: 202778

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-06-08

202778 / 1

Active Ingredient

DOXYCYCLINE

Application Number

202778

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2012-06-08

Regulatory Status

Discontinued

1982
29 Mar
RX Application: 62337

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1982-03-29

62337 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62337

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1982-03-29

Regulatory Status

RX

1982
29 Mar
RX Application: 62337

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1982-03-29

62337 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62337

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1982-03-29

Regulatory Status

RX

2018
22 Jun
Discontinued Application: 208227

Drug Name

DUTASTERIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2018-06-22

208227 / 1

Active Ingredient

DUTASTERIDE

Application Number

208227

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2018-06-22

Regulatory Status

Discontinued

2021
16 Jun
Discontinued Application: 78509

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2021-06-16

78509 / 1

Active Ingredient

EFAVIRENZ

Application Number

78509

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2021-06-16

Regulatory Status

Discontinued

2021
13 Jan
RX Application: 91055

Drug Name

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2021-01-13

91055 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

91055

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2021-01-13

Regulatory Status

RX

2018
18 Jun
Discontinued Application: 207536

Drug Name

FLUCYTOSINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-06-18

207536 / 1

Active Ingredient

FLUCYTOSINE

Application Number

207536

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-06-18

Regulatory Status

Discontinued

2018
18 Jun
Discontinued Application: 207536

Drug Name

FLUCYTOSINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-06-18

207536 / 2

Active Ingredient

FLUCYTOSINE

Application Number

207536

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-06-18

Regulatory Status

Discontinued

2020
17 Apr
RX Application: 212632

Drug Name

FLUCYTOSINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-04-17

212632 / 1

Active Ingredient

FLUCYTOSINE

Application Number

212632

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-04-17

Regulatory Status

RX

2020
17 Apr
RX Application: 212632

Drug Name

FLUCYTOSINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-04-17

212632 / 2

Active Ingredient

FLUCYTOSINE

Application Number

212632

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-04-17

Regulatory Status

RX

2024
13 Sep
RX Application: 212683

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2024-09-13

212683 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

212683

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2024-09-13

Regulatory Status

RX

2024
05 Apr
RX Application: 212684

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-04-05

212684 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

212684

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-04-05

Regulatory Status

RX

2024
05 Apr
RX Application: 212684

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-04-05

212684 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

212684

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-04-05

Regulatory Status

RX

2013
12 Jul
RX Application: 203244

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2013-07-12

203244 / 1

Active Ingredient

GABAPENTIN

Application Number

203244

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2013-07-12

Regulatory Status

RX

2013
12 Jul
RX Application: 203244

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2013-07-12

203244 / 2

Active Ingredient

GABAPENTIN

Application Number

203244

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2013-07-12

Regulatory Status

RX

2018
14 May
RX Application: 206943

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-05-14

206943 / 1

Active Ingredient

GABAPENTIN

Application Number

206943

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-05-14

Regulatory Status

RX

2018
14 May
RX Application: 206943

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2018-05-14

206943 / 2

Active Ingredient

GABAPENTIN

Application Number

206943

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2018-05-14

Regulatory Status

RX

2018
14 May
RX Application: 206943

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2018-05-14

206943 / 3

Active Ingredient

GABAPENTIN

Application Number

206943

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2018-05-14

Regulatory Status

RX

2024
04 Mar
RX Application: 211313

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2024-03-04

211313 / 1

Active Ingredient

GABAPENTIN

Application Number

211313

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2024-03-04

Regulatory Status

RX

2024
04 Mar
RX Application: 211313

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2024-03-04

211313 / 2

Active Ingredient

GABAPENTIN

Application Number

211313

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2024-03-04

Regulatory Status

RX

2024
20 Dec
RX Application: 211313

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-12-20

211313 / 3

Active Ingredient

GABAPENTIN

Application Number

211313

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-12-20

Regulatory Status

RX

2024
20 Dec
RX Application: 211313

Drug Name

GABAPENTIN

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2024-12-20

211313 / 4

Active Ingredient

GABAPENTIN

Application Number

211313

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2024-12-20

Regulatory Status

RX

2018
16 Oct
RX Application: 211314

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-10-16

211314 / 1

Active Ingredient

GABAPENTIN

Application Number

211314

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-10-16

Regulatory Status

RX

2018
16 Oct
RX Application: 211314

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2018-10-16

211314 / 2

Active Ingredient

GABAPENTIN

Application Number

211314

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2018-10-16

Regulatory Status

RX

2018
16 Oct
RX Application: 211314

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2018-10-16

211314 / 3

Active Ingredient

GABAPENTIN

Application Number

211314

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2018-10-16

Regulatory Status

RX

2013
03 May
RX Application: 200770

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-05-03

200770 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200770

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-05-03

Regulatory Status

RX

2013
03 May
RX Application: 200770

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-05-03

200770 / 2

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200770

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-05-03

Regulatory Status

RX

2013
03 May
RX Application: 200770

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-05-03

200770 / 3

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200770

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-05-03

Regulatory Status

RX

2019
25 Jun
Discontinued Application: 200770

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2019-06-25

200770 / 4

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

200770

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2019-06-25

Regulatory Status

Discontinued

2006
06 Nov
Discontinued Application: 77723

Drug Name

HYDROCODONE

Product Number

3

Dosage Form

-

Strength

5MG;200MG

Approval Date

2006-11-06

77723 / 3

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

77723

Product Number

3

Dosage Form

-

Strength

5MG;200MG

Approval Date

2006-11-06

Regulatory Status

Discontinued

2006
06 Nov
Discontinued Application: 77723

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2006-11-06

77723 / 1

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

77723

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2006-11-06

Regulatory Status

Discontinued

2006
06 Nov
Discontinued Application: 77723

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

2

Dosage Form

-

Strength

10MG;200MG

Approval Date

2006-11-06

77723 / 2

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

77723

Product Number

2

Dosage Form

-

Strength

10MG;200MG

Approval Date

2006-11-06

Regulatory Status

Discontinued

2017
27 Apr
RX Application: 207029

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-27

207029 / 1

Active Ingredient

HYDROCORTISONE

Application Number

207029

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-04-27

Regulatory Status

RX

2017
27 Apr
RX Application: 207029

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-04-27

207029 / 2

Active Ingredient

HYDROCORTISONE

Application Number

207029

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-04-27

Regulatory Status

RX

2017
27 Apr
RX Application: 207029

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2017-04-27

207029 / 3

Active Ingredient

HYDROCORTISONE

Application Number

207029

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2017-04-27

Regulatory Status

RX

2009
05 Feb
RX Application: 78329

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2009-02-05

78329 / 1

Active Ingredient

IBUPROFEN

Application Number

78329

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2009-02-05

Regulatory Status

RX

2009
05 Feb
RX Application: 78329

Drug Name

IBUPROFEN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2009-02-05

78329 / 2

Active Ingredient

IBUPROFEN

Application Number

78329

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2009-02-05

Regulatory Status

RX

2009
05 Feb
RX Application: 78329

Drug Name

IBUPROFEN

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2009-02-05

78329 / 3

Active Ingredient

IBUPROFEN

Application Number

78329

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2009-02-05

Regulatory Status

RX

2011
28 Mar
OTC Application: 79129

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2011-03-28

79129 / 1

Active Ingredient

IBUPROFEN

Application Number

79129

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2011-03-28

Regulatory Status

OTC

2011
04 Apr
OTC Application: 91355

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2011-04-04

91355 / 1

Active Ingredient

IBUPROFEN

Application Number

91355

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2011-04-04

Regulatory Status

OTC

2018
29 Jun
Discontinued Application: 206989

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-06-29

206989 / 1

Active Ingredient

IBUPROFEN

Application Number

206989

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-06-29

Regulatory Status

Discontinued

2017
30 May
Discontinued Application: 207052

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-05-30

207052 / 1

Active Ingredient

IBUPROFEN

Application Number

207052

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-05-30

Regulatory Status

Discontinued

2021
22 Feb
OTC Application: 211666

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2021-02-22

211666 / 1

Active Ingredient

IBUPROFEN

Application Number

211666

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2021-02-22

Regulatory Status

OTC

2022
09 Jun
Discontinued Application: 214071

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

50MG/1.25ML

Approval Date

2022-06-09

214071 / 1

Active Ingredient

IBUPROFEN

Application Number

214071

Product Number

1

Dosage Form

-

Strength

50MG/1.25ML

Approval Date

2022-06-09

Regulatory Status

Discontinued

2022
27 May
RX Application: 215311

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2022-05-27

215311 / 1

Active Ingredient

IBUPROFEN

Application Number

215311

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2022-05-27

Regulatory Status

RX

2006
14 Aug
OTC Application: 77628

Drug Name

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG;30MG

Approval Date

2006-08-14

77628 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

77628

Product Number

1

Dosage Form

-

Strength

200MG;30MG

Approval Date

2006-08-14

Regulatory Status

OTC

2014
24 Jun
Discontinued Application: 202002

Drug Name

IMIQUIMOD

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2014-06-24

202002 / 1

Active Ingredient

IMIQUIMOD

Application Number

202002

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2014-06-24

Regulatory Status

Discontinued

2019
02 Jul
Discontinued Application: 206410

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2019-07-02

206410 / 1

Active Ingredient

ITRACONAZOLE

Application Number

206410

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2019-07-02

Regulatory Status

Discontinued

2018
18 Jun
RX Application: 210457

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-06-18

210457 / 1

Active Ingredient

KETOCONAZOLE

Application Number

210457

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2018-06-18

Regulatory Status

RX

2018
19 Apr
RX Application: 90457

Drug Name

LAMIVUDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2018-04-19

90457 / 1

Active Ingredient

LAMIVUDINE

Application Number

90457

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2018-04-19

Regulatory Status

RX

2018
19 Apr
RX Application: 90457

Drug Name

LAMIVUDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2018-04-19

90457 / 2

Active Ingredient

LAMIVUDINE

Application Number

90457

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2018-04-19

Regulatory Status

RX

2009
15 Jan
Discontinued Application: 78042

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-01-15

78042 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78042

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78042

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-01-15

78042 / 2

Active Ingredient

LEVETIRACETAM

Application Number

78042

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78042

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-01-15

78042 / 3

Active Ingredient

LEVETIRACETAM

Application Number

78042

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78042

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-01-15

78042 / 4

Active Ingredient

LEVETIRACETAM

Application Number

78042

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-01-15

Regulatory Status

Discontinued

2009
15 Jan
Discontinued Application: 78582

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-01-15

78582 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78582

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-01-15

Regulatory Status

Discontinued

2023
20 Nov
Discontinued Application: 214673

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2023-11-20

214673 / 1

Active Ingredient

LEVETIRACETAM

Application Number

214673

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2023-11-20

Regulatory Status

Discontinued

2018
11 Dec
RX Application: 210958

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-12-11

210958 / 1

Active Ingredient

LIDOCAINE

Application Number

210958

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-12-11

Regulatory Status

RX

2002
01 Jul
Discontinued Application: 76071

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

76071 / 1

Active Ingredient

LISINOPRIL

Application Number

76071

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76071

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

76071 / 2

Active Ingredient

LISINOPRIL

Application Number

76071

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76071

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

76071 / 3

Active Ingredient

LISINOPRIL

Application Number

76071

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76071

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

76071 / 4

Active Ingredient

LISINOPRIL

Application Number

76071

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76071

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

76071 / 5

Active Ingredient

LISINOPRIL

Application Number

76071

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76071

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

76071 / 6

Active Ingredient

LISINOPRIL

Application Number

76071

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2010
06 Oct
RX Application: 90382

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

90382 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90382

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

Regulatory Status

RX

2010
06 Oct
RX Application: 90382

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

90382 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90382

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

Regulatory Status

RX

2010
06 Oct
RX Application: 90382

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

90382 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90382

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

Regulatory Status

RX

2017
23 May
Discontinued Application: 202350

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-05-23

202350 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

202350

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2017-05-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 202350

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-05-23

202350 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

202350

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2017-05-23

Regulatory Status

Discontinued

1985
29 Jan
Discontinued Application: 70039

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-01-29

70039 / 1

Active Ingredient

METRONIDAZOLE

Application Number

70039

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1985-01-29

Regulatory Status

Discontinued

1985
29 Jan
Discontinued Application: 70040

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-01-29

70040 / 1

Active Ingredient

METRONIDAZOLE

Application Number

70040

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1985-01-29

Regulatory Status

Discontinued

2010
10 Jun
RX Application: 90055

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2010-06-10

90055 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90055

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2010-06-10

Regulatory Status

RX

2010
10 Jun
RX Application: 90456

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2010-06-10

90456 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90456

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2010-06-10

Regulatory Status

RX

2012
22 May
Discontinued Application: 78195

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

78195 / 1

Active Ingredient

NEVIRAPINE

Application Number

78195

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-05-22

Regulatory Status

Discontinued

2013
14 Aug
RX Application: 201355

Drug Name

NITROFURANTOIN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2013-08-14

201355 / 1

Active Ingredient

NITROFURANTOIN

Application Number

201355

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

2013-08-14

Regulatory Status

RX

2018
29 Jan
Discontinued Application: 210077

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

2018-01-29

210077 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

210077

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

2018-01-29

Regulatory Status

Discontinued

2003
29 May
Discontinued Application: 75876

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-05-29

75876 / 1

Active Ingredient

OMEPRAZOLE

Application Number

75876

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-05-29

Regulatory Status

Discontinued

2003
29 May
Discontinued Application: 75876

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-05-29

75876 / 2

Active Ingredient

OMEPRAZOLE

Application Number

75876

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2003-05-29

Regulatory Status

Discontinued

2009
21 Jan
Discontinued Application: 75876

Drug Name

OMEPRAZOLE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

75876 / 3

Active Ingredient

OMEPRAZOLE

Application Number

75876

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2009-01-21

Regulatory Status

Discontinued

2018
08 Jun
RX Application: 209421

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-06-08

209421 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

209421

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-06-08

Regulatory Status

RX

2018
08 Jun
RX Application: 209421

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2018-06-08

209421 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

209421

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2018-06-08

Regulatory Status

RX

2018
08 Jun
RX Application: 209421

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-06-08

209421 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

209421

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-06-08

Regulatory Status

RX

2022
13 Jan
RX Application: 211894

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2022-01-13

211894 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

211894

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2022-01-13

Regulatory Status

RX

2020
17 Dec
RX Application: 208165

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-12-17

208165 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

208165

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-12-17

Regulatory Status

RX

2015
13 Apr
RX Application: 204559

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

2015-04-13

204559 / 1

Active Ingredient

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

Application Number

204559

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2015-04-13

Regulatory Status

RX

2002
27 Nov
Discontinued Application: 76061

Drug Name

PERGOLIDE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2002-11-27

76061 / 1

Active Ingredient

PERGOLIDE MESYLATE

Application Number

76061

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2002-11-27

Regulatory Status

Discontinued

2002
27 Nov
Discontinued Application: 76061

Drug Name

PERGOLIDE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2002-11-27

76061 / 2

Active Ingredient

PERGOLIDE MESYLATE

Application Number

76061

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2002-11-27

Regulatory Status

Discontinued

2002
27 Nov
Discontinued Application: 76061

Drug Name

PERGOLIDE MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2002-11-27

76061 / 3

Active Ingredient

PERGOLIDE MESYLATE

Application Number

76061

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2002-11-27

Regulatory Status

Discontinued

2017
20 Jun
Discontinued Application: 206136

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-20

206136 / 1

Active Ingredient

PIROXICAM

Application Number

206136

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-20

Regulatory Status

Discontinued

2017
20 Jun
Discontinued Application: 206136

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-06-20

206136 / 2

Active Ingredient

PIROXICAM

Application Number

206136

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-06-20

Regulatory Status

Discontinued

2018
26 Jan
RX Application: 210347

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-01-26

210347 / 1

Active Ingredient

PIROXICAM

Application Number

210347

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-01-26

Regulatory Status

RX

2018
26 Jan
RX Application: 210347

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-01-26

210347 / 2

Active Ingredient

PIROXICAM

Application Number

210347

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-01-26

Regulatory Status

RX

2016
24 Aug
OTC Application: 203928

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2016-08-24

203928 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

203928

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2016-08-24

Regulatory Status

OTC

2016
24 Aug
OTC Application: 203928

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2016-08-24

203928 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

203928

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2016-08-24

Regulatory Status

OTC

2018
21 Dec
RX Application: 204558

Drug Name

POLYETHYLENE GLYCOL 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

2018-12-21

204558 / 1

Active Ingredient

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

Application Number

204558

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2018-12-21

Regulatory Status

RX

2015
08 Dec
Discontinued Application: 205549

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-12-08

205549 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

205549

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-12-08

Regulatory Status

Discontinued

2015
08 Dec
Discontinued Application: 205549

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-12-08

205549 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

205549

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-12-08

Regulatory Status

Discontinued

2019
22 Jan
Discontinued Application: 206881

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2019-01-22

206881 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

206881

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2019-01-22

Regulatory Status

Discontinued

2019
22 Jan
Discontinued Application: 206881

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2019-01-22

206881 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

206881

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2019-01-22

Regulatory Status

Discontinued

2019
17 Jun
Discontinued Application: 210097

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2019-06-17

210097 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210097

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2019-06-17

Regulatory Status

Discontinued

2018
31 Aug
RX Application: 210733

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2018-08-31

210733 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210733

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2018-08-31

Regulatory Status

RX

2018
31 Aug
RX Application: 210733

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2018-08-31

210733 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210733

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2018-08-31

Regulatory Status

RX

2022
17 Nov
Discontinued Application: 211665

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2022-11-17

211665 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211665

Product Number

1

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2022-11-17

Regulatory Status

Discontinued

2024
16 Jan
Discontinued Application: 211665

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2024-01-16

211665 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211665

Product Number

2

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2024-01-16

Regulatory Status

Discontinued

2021
11 Mar
RX Application: 211667

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2021-03-11

211667 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211667

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2021-03-11

Regulatory Status

RX

2017
11 Sep
RX Application: 206813

Drug Name

POTASSIUM CITRATE

Product Number

1

Dosage Form

-

Strength

5MEQ

Approval Date

2017-09-11

206813 / 1

Active Ingredient

POTASSIUM CITRATE

Application Number

206813

Product Number

1

Dosage Form

-

Strength

5MEQ

Approval Date

2017-09-11

Regulatory Status

RX

2017
11 Sep
RX Application: 206813

Drug Name

POTASSIUM CITRATE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2017-09-11

206813 / 2

Active Ingredient

POTASSIUM CITRATE

Application Number

206813

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2017-09-11

Regulatory Status

RX

2017
11 Sep
RX Application: 206813

Drug Name

POTASSIUM CITRATE

Product Number

3

Dosage Form

-

Strength

15MEQ

Approval Date

2017-09-11

206813 / 3

Active Ingredient

POTASSIUM CITRATE

Application Number

206813

Product Number

3

Dosage Form

-

Strength

15MEQ

Approval Date

2017-09-11

Regulatory Status

RX

2014
03 Jun
RX Application: 202702

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2014-06-03

202702 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

202702

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 202702

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2014-06-03

202702 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

202702

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 202702

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2014-06-03

202702 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

202702

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 202702

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2014-06-03

202702 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

202702

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 202702

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2014-06-03

202702 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

202702

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 202702

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2014-06-03

202702 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

202702

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2014-06-03

Regulatory Status

RX

2021
11 Feb
RX Application: 208412

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-02-11

208412 / 1

Active Ingredient

PREDNISONE

Application Number

208412

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-02-11

Regulatory Status

RX

2021
11 Feb
RX Application: 208412

Drug Name

PREDNISONE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-02-11

208412 / 2

Active Ingredient

PREDNISONE

Application Number

208412

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2021-02-11

Regulatory Status

RX

2022
11 Jan
RX Application: 208412

Drug Name

PREDNISONE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2022-01-11

208412 / 3

Active Ingredient

PREDNISONE

Application Number

208412

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2022-01-11

Regulatory Status

RX

2020
20 Nov
RX Application: 208412

Drug Name

PREDNISONE

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2020-11-20

208412 / 4

Active Ingredient

PREDNISONE

Application Number

208412

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2020-11-20

Regulatory Status

RX

2020
20 Nov
RX Application: 208412

Drug Name

PREDNISONE

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2020-11-20

208412 / 5

Active Ingredient

PREDNISONE

Application Number

208412

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2020-11-20

Regulatory Status

RX

2020
02 Sep
RX Application: 210785

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-09-02

210785 / 1

Active Ingredient

PREDNISONE

Application Number

210785

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-09-02

Regulatory Status

RX

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-01-24

209883 / 1

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-01-24

209883 / 2

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2024-01-24

209883 / 3

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2024-01-24

209883 / 4

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2024-01-24

209883 / 5

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2024-01-24

209883 / 6

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2024-01-24

209883 / 7

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2024
24 Jan
Discontinued Application: 209883

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2024-01-24

209883 / 8

Active Ingredient

PREGABALIN

Application Number

209883

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2024-01-24

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-04-26

215755 / 1

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-04-26

215755 / 2

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2023-04-26

215755 / 3

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2023-04-26

215755 / 4

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2023-04-26

215755 / 5

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2023-04-26

215755 / 6

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2023-04-26

215755 / 7

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2023
26 Apr
Discontinued Application: 215755

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2023-04-26

215755 / 8

Active Ingredient

PREGABALIN

Application Number

215755

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2023-04-26

Regulatory Status

Discontinued

2009
13 Mar
RX Application: 40891

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

6.25MG/5ML

Approval Date

2009-03-13

40891 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40891

Product Number

1

Dosage Form

-

Strength

6.25MG/5ML

Approval Date

2009-03-13

Regulatory Status

RX

2017
30 Jun
Discontinued Application: 209177

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2017-06-30

209177 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

209177

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2017-06-30

Regulatory Status

Discontinued

2017
30 Jun
Discontinued Application: 209177

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2017-06-30

209177 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

209177

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2017-06-30

Regulatory Status

Discontinued

2017
30 Jun
Discontinued Application: 209177

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2017-06-30

209177 / 3

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

209177

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2017-06-30

Regulatory Status

Discontinued

2011
28 Jun
Discontinued Application: 200536

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-06-28

200536 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

200536

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-06-28

Regulatory Status

Discontinued

2012
29 Feb
Discontinued Application: 201745

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-02-29

201745 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

201745

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-02-29

Regulatory Status

Discontinued

2016
22 Aug
Discontinued Application: 205512

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2016-08-22

205512 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

205512

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2016-08-22

Regulatory Status

Discontinued

2016
22 Aug
Discontinued Application: 205512

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2016-08-22

205512 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

205512

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2016-08-22

Regulatory Status

Discontinued

2018
05 Mar
Discontinued Application: 209160

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-03-05

209160 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

209160

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2018-03-05

Regulatory Status

Discontinued

2018
22 Feb
Discontinued Application: 209161

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-02-22

209161 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

209161

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-02-22

Regulatory Status

Discontinued

2018
01 Aug
Discontinued Application: 210010

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-08-01

210010 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

210010

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-08-01

Regulatory Status

Discontinued

2018
01 Aug
Discontinued Application: 210010

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-08-01

210010 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

210010

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-08-01

Regulatory Status

Discontinued

2020
30 Mar
RX Application: 208247

Drug Name

ROFLUMILAST

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2020-03-30

208247 / 1

Active Ingredient

ROFLUMILAST

Application Number

208247

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2020-03-30

Regulatory Status

RX

2023
20 Jun
RX Application: 208247

Drug Name

ROFLUMILAST

Product Number

2

Dosage Form

-

Strength

250MCG

Approval Date

2023-06-20

208247 / 2

Active Ingredient

ROFLUMILAST

Application Number

208247

Product Number

2

Dosage Form

-

Strength

250MCG

Approval Date

2023-06-20

Regulatory Status

RX

2007
06 Feb
RX Application: 76881

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

76881 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76881

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

Regulatory Status

RX

2007
06 Feb
RX Application: 76881

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

76881 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76881

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

Regulatory Status

RX

2007
06 Feb
RX Application: 76881

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

76881 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76881

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

Regulatory Status

RX

2006
30 Jun
RX Application: 76934

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2006-06-30

76934 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76934

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2006-06-30

Regulatory Status

RX

2024
09 May
RX Application: 211915

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2024-05-09

211915 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

211915

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2024-05-09

Regulatory Status

RX

2024
21 May
RX Application: 216474

Drug Name

SUCRALFATE

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2024-05-21

216474 / 1

Active Ingredient

SUCRALFATE

Application Number

216474

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2024-05-21

Regulatory Status

RX

2014
22 Jul
RX Application: 90687

Drug Name

TACROLIMUS

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2014-07-22

90687 / 1

Active Ingredient

TACROLIMUS

Application Number

90687

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2014-07-22

Regulatory Status

RX

2014
22 Jul
RX Application: 90687

Drug Name

TACROLIMUS

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2014-07-22

90687 / 2

Active Ingredient

TACROLIMUS

Application Number

90687

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2014-07-22

Regulatory Status

RX

2014
22 Jul
RX Application: 90687

Drug Name

TACROLIMUS

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2014-07-22

90687 / 3

Active Ingredient

TACROLIMUS

Application Number

90687

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2014-07-22

Regulatory Status

RX

2018
26 Jan
RX Application: 90742

Drug Name

TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2018-01-26

90742 / 1

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

90742

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2018-01-26

Regulatory Status

RX

2024
05 Sep
RX Application: 215312

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2024-09-05

215312 / 1

Active Ingredient

THEOPHYLLINE

Application Number

215312

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2024-09-05

Regulatory Status

RX

2024
05 Sep
RX Application: 215312

Drug Name

THEOPHYLLINE

Product Number

2

Dosage Form

-

Strength

450MG

Approval Date

2024-09-05

215312 / 2

Active Ingredient

THEOPHYLLINE

Application Number

215312

Product Number

2

Dosage Form

-

Strength

450MG

Approval Date

2024-09-05

Regulatory Status

RX

2009
14 Oct
RX Application: 78418

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-10-14

78418 / 1

Active Ingredient

TOPIRAMATE

Application Number

78418

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-10-14

Regulatory Status

RX

2009
14 Oct
RX Application: 78418

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-10-14

78418 / 2

Active Ingredient

TOPIRAMATE

Application Number

78418

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-10-14

Regulatory Status

RX

2026
02 Feb
RX Application: 78418

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2026-02-02

78418 / 3

Active Ingredient

TOPIRAMATE

Application Number

78418

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2026-02-02

Regulatory Status

RX

2011
28 Nov
RX Application: 202075

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-11-28

202075 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

202075

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2011-11-28

Regulatory Status

RX

2026
23 Mar
RX Application: 202075

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2026-03-23

202075 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

202075

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2026-03-23

Regulatory Status

RX

2019
11 Feb
Discontinued Application: 210346

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2019-02-11

210346 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

210346

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2019-02-11

Regulatory Status

Discontinued

2019
11 Feb
Discontinued Application: 210346

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2019-02-11

210346 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

210346

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2019-02-11

Regulatory Status

Discontinued

2019
11 Feb
Discontinued Application: 210346

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

2019-02-11

210346 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

210346

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

2019-02-11

Regulatory Status

Discontinued

2020
01 Jun
RX Application: 212356

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2020-06-01

212356 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

212356

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2020-06-01

Regulatory Status

RX

2021
22 Jan
RX Application: 210344

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2021-01-22

210344 / 1

Active Ingredient

URSODIOL

Application Number

210344

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2021-01-22

Regulatory Status

RX

2026
16 Jan
RX Application: 210344

Drug Name

URSODIOL

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2026-01-16

210344 / 2

Active Ingredient

URSODIOL

Application Number

210344

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2026-01-16

Regulatory Status

RX

2020
20 Aug
RX Application: 213504

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-08-20

213504 / 1

Active Ingredient

URSODIOL

Application Number

213504

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-08-20

Regulatory Status

RX

2020
20 Aug
RX Application: 213504

Drug Name

URSODIOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-08-20

213504 / 2

Active Ingredient

URSODIOL

Application Number

213504

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2020-08-20

Regulatory Status

RX

2012
09 Apr
RX Application: 65490

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2012-04-09

65490 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

65490

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2012-04-09

Regulatory Status

RX

2012
09 Apr
RX Application: 65490

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2012-04-09

65490 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

65490

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2012-04-09

Regulatory Status

RX

2007
23 Apr
Discontinued Application: 76062

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

76062 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

76062

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 76062

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

76062 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

76062

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

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  • FDA Approved Drugs Database
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Drug Status Breakdown
227 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACARBOSE

Application Number

90912

Product Number

1

Active Ingredient

ACARBOSE

Dosage Form

-

Strength

25MG

FDA Approved Drug Data

Approved drug product information

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