Jubilant Cadista Pharmaceuticals Inc.
FDA Approved Drugs

Jubilant Cadista Pharmaceuticals Inc.

FDA Approved Drugs Database

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

Discontinued RX
  • Total Records 73
  • Latest Approval Date Dec 01, 2023
  • Data Source FDA
  • First Approval Date Feb 01, 1988
All
73
View
Discontinued
19
View
RX
54
View
Company Overview

Company

Jubilant Cadista Pharmaceuticals Inc.

Country

U.S.A

Website

Visit Website

Email

customer.service@cadista.com

Social Profiles

Company Snapshot

Jubilant Cadista Pharmaceuticals Inc.

207, Kiley Drive, Salisbury, Maryland-21801, USA

U.S.A

www.cadista.com/ customer.service@cadista.com View on Map
FDA Approved Drug Records ( 73 records )
2010
18 Feb
Discontinued Application: 90557

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2010-02-18

90557 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

90557

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2010-02-18

Regulatory Status

Discontinued

2010
18 Feb
Discontinued Application: 90557

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2010-02-18

90557 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

90557

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2010-02-18

Regulatory Status

Discontinued

2010
18 Feb
Discontinued Application: 90557

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2010-02-18

90557 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

90557

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2010-02-18

Regulatory Status

Discontinued

2010
18 Feb
Discontinued Application: 90557

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2010-02-18

90557 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

90557

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2010-02-18

Regulatory Status

Discontinued

1988
01 Feb
Discontinued Application: 71940

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1988-02-01

71940 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

71940

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1988-02-01

Regulatory Status

Discontinued

2019
25 Apr
Discontinued Application: 206714

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-04-25

206714 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

206714

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-04-25

Regulatory Status

Discontinued

2019
25 Apr
Discontinued Application: 206714

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2019-04-25

206714 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

206714

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2019-04-25

Regulatory Status

Discontinued

2019
21 Oct
RX Application: 212218

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-10-21

212218 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

212218

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-10-21

Regulatory Status

RX

2019
21 Oct
RX Application: 212218

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-10-21

212218 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

212218

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-10-21

Regulatory Status

RX

2019
21 Oct
RX Application: 212218

Drug Name

CLOMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-10-21

212218 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

212218

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-10-21

Regulatory Status

RX

2006
19 Apr
RX Application: 77563

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-04-19

77563 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

77563

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-04-19

Regulatory Status

RX

2006
19 Apr
RX Application: 77563

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-04-19

77563 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

77563

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-04-19

Regulatory Status

RX

2017
25 Aug
RX Application: 77563

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2017-08-25

77563 / 3

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

77563

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2017-08-25

Regulatory Status

RX

2022
14 Mar
RX Application: 215483

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-03-14

215483 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215483

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2022-03-14

Regulatory Status

RX

2022
14 Mar
RX Application: 215483

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-03-14

215483 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215483

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-03-14

Regulatory Status

RX

2022
14 Mar
RX Application: 215483

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-03-14

215483 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215483

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-03-14

Regulatory Status

RX

2022
14 Mar
RX Application: 215483

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-03-14

215483 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215483

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-03-14

Regulatory Status

RX

2022
14 Mar
RX Application: 215483

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-03-14

215483 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

215483

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-03-14

Regulatory Status

RX

2017
22 Dec
Discontinued Application: 209423

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2017-12-22

209423 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

209423

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2017-12-22

Regulatory Status

Discontinued

2018
10 Sep
Discontinued Application: 210017

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2018-09-10

210017 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

210017

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2018-09-10

Regulatory Status

Discontinued

2021
18 Feb
RX Application: 214391

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

214391 / 1

Active Ingredient

DROXIDOPA

Application Number

214391

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 214391

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

214391 / 2

Active Ingredient

DROXIDOPA

Application Number

214391

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 214391

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

214391 / 3

Active Ingredient

DROXIDOPA

Application Number

214391

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

RX

2012
12 Sep
RX Application: 202280

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-12

202280 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

202280

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-12

Regulatory Status

RX

2012
12 Sep
RX Application: 202280

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-12

202280 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

202280

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-12

Regulatory Status

RX

2012
12 Sep
RX Application: 202280

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-12

202280 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

202280

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-12

Regulatory Status

RX

2005
14 Jun
Discontinued Application: 40514

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-06-14

40514 / 1

Active Ingredient

FOLIC ACID

Application Number

40514

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-06-14

Regulatory Status

Discontinued

2007
04 Sep
Discontinued Application: 40809

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-09-04

40809 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40809

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-09-04

Regulatory Status

Discontinued

2007
04 Sep
Discontinued Application: 40809

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-09-04

40809 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40809

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-09-04

Regulatory Status

Discontinued

2008
11 Feb
RX Application: 78391

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-02-11

78391 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

78391

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-02-11

Regulatory Status

RX

2009
27 Jan
RX Application: 79132

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

79132 / 1

Active Ingredient

LAMOTRIGINE

Application Number

79132

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

Regulatory Status

RX

2009
27 Jan
RX Application: 79132

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

79132 / 2

Active Ingredient

LAMOTRIGINE

Application Number

79132

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

Regulatory Status

RX

2009
27 Jan
RX Application: 79132

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

79132 / 3

Active Ingredient

LAMOTRIGINE

Application Number

79132

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

Regulatory Status

RX

2009
27 Jan
RX Application: 79132

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

79132 / 4

Active Ingredient

LAMOTRIGINE

Application Number

79132

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

Regulatory Status

RX

2023
05 Jul
RX Application: 217840

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-07-05

217840 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

217840

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2023-07-05

Regulatory Status

RX

2012
18 Sep
RX Application: 201170

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2012-09-18

201170 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

201170

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2012-09-18

Regulatory Status

RX

2012
18 Sep
RX Application: 201170

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2012-09-18

201170 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

201170

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2012-09-18

Regulatory Status

RX

2012
18 Sep
RX Application: 201170

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2012-09-18

201170 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

201170

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2012-09-18

Regulatory Status

RX

2012
18 Sep
RX Application: 201845

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2012-09-18

201845 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

201845

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2012-09-18

Regulatory Status

RX

2012
18 Sep
RX Application: 201845

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2012-09-18

201845 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

201845

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2012-09-18

Regulatory Status

RX

2012
18 Sep
RX Application: 201845

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2012-09-18

201845 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

201845

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2012-09-18

Regulatory Status

RX

2010
04 Jun
RX Application: 40659

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2010-06-04

40659 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

40659

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2010-06-04

Regulatory Status

RX

2010
04 Jun
RX Application: 40659

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2010-06-04

40659 / 2

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

40659

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2010-06-04

Regulatory Status

RX

2023
01 Dec
RX Application: 217675

Drug Name

METHENAMINE HIPPURATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-12-01

217675 / 1

Active Ingredient

METHENAMINE HIPPURATE

Application Number

217675

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-12-01

Regulatory Status

RX

1997
31 Oct
RX Application: 40189

Drug Name

METHYLPREDNISOLONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1997-10-31

40189 / 1

Active Ingredient

METHYLPREDNISOLONE

Application Number

40189

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1997-10-31

Regulatory Status

RX

1997
31 Oct
RX Application: 40189

Drug Name

METHYLPREDNISOLONE

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1997-10-31

40189 / 2

Active Ingredient

METHYLPREDNISOLONE

Application Number

40189

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

1997-10-31

Regulatory Status

RX

2007
20 Jul
RX Application: 40189

Drug Name

METHYLPREDNISOLONE

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2007-07-20

40189 / 3

Active Ingredient

METHYLPREDNISOLONE

Application Number

40189

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2007-07-20

Regulatory Status

RX

2007
20 Jul
RX Application: 40189

Drug Name

METHYLPREDNISOLONE

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2007-07-20

40189 / 4

Active Ingredient

METHYLPREDNISOLONE

Application Number

40189

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2007-07-20

Regulatory Status

RX

2014
15 Dec
Discontinued Application: 90661

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2014-12-15

90661 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90661

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2014-12-15

Regulatory Status

Discontinued

2014
15 Dec
Discontinued Application: 90762

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2014-12-15

90762 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90762

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2014-12-15

Regulatory Status

Discontinued

2010
25 Jan
Discontinued Application: 90239

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2010-01-25

90239 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

90239

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2010-01-25

Regulatory Status

Discontinued

2010
25 Jan
Discontinued Application: 90239

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2010-01-25

90239 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

90239

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2010-01-25

Regulatory Status

Discontinued

2010
25 Jan
Discontinued Application: 90239

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2010-01-25

90239 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

90239

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2010-01-25

Regulatory Status

Discontinued

2001
29 Aug
RX Application: 40362

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-08-29

40362 / 1

Active Ingredient

PREDNISONE

Application Number

40362

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-08-29

Regulatory Status

RX

2001
29 Aug
RX Application: 40362

Drug Name

PREDNISONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-08-29

40362 / 2

Active Ingredient

PREDNISONE

Application Number

40362

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-08-29

Regulatory Status

RX

2005
29 Jun
RX Application: 40362

Drug Name

PREDNISONE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-06-29

40362 / 3

Active Ingredient

PREDNISONE

Application Number

40362

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-06-29

Regulatory Status

RX

2023
17 Apr
RX Application: 40362

Drug Name

PREDNISONE

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2023-04-17

40362 / 4

Active Ingredient

PREDNISONE

Application Number

40362

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2023-04-17

Regulatory Status

RX

2023
17 Apr
RX Application: 40362

Drug Name

PREDNISONE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-04-17

40362 / 5

Active Ingredient

PREDNISONE

Application Number

40362

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-04-17

Regulatory Status

RX

2005
06 Jun
RX Application: 40611

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-06-06

40611 / 1

Active Ingredient

PREDNISONE

Application Number

40611

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-06-06

Regulatory Status

RX

1998
27 Feb
RX Application: 40268

Drug Name

PROCOMP

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-02-27

40268 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

40268

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-02-27

Regulatory Status

RX

1998
27 Feb
RX Application: 40268

Drug Name

PROCOMP

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-02-27

40268 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

40268

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-02-27

Regulatory Status

RX

2009
23 Mar
RX Application: 78828

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2009-03-23

78828 / 1

Active Ingredient

RISPERIDONE

Application Number

78828

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2009-03-23

Regulatory Status

RX

2009
23 Mar
RX Application: 78828

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2009-03-23

78828 / 2

Active Ingredient

RISPERIDONE

Application Number

78828

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2009-03-23

Regulatory Status

RX

2009
23 Mar
RX Application: 78828

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2009-03-23

78828 / 3

Active Ingredient

RISPERIDONE

Application Number

78828

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2009-03-23

Regulatory Status

RX

2009
23 Mar
RX Application: 78828

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2009-03-23

78828 / 4

Active Ingredient

RISPERIDONE

Application Number

78828

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2009-03-23

Regulatory Status

RX

2009
23 Mar
RX Application: 78828

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2009-03-23

78828 / 5

Active Ingredient

RISPERIDONE

Application Number

78828

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2009-03-23

Regulatory Status

RX

2009
23 Mar
RX Application: 78828

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2009-03-23

78828 / 6

Active Ingredient

RISPERIDONE

Application Number

78828

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2009-03-23

Regulatory Status

RX

2016
18 May
Discontinued Application: 203352

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2016-05-18

203352 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

203352

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2016-05-18

Regulatory Status

Discontinued

2016
18 May
Discontinued Application: 203352

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

27MG/3ML (9MG/ML)

Approval Date

2016-05-18

203352 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

203352

Product Number

2

Dosage Form

-

Strength

27MG/3ML (9MG/ML)

Approval Date

2016-05-18

Regulatory Status

Discontinued

2004
20 Dec
RX Application: 75317

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2004-12-20

75317 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75317

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2004-12-20

Regulatory Status

RX

2004
20 Dec
RX Application: 75317

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2004-12-20

75317 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75317

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2004-12-20

Regulatory Status

RX

2004
20 Dec
RX Application: 75317

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2004-12-20

75317 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75317

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2004-12-20

Regulatory Status

RX

2004
20 Dec
RX Application: 75317

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-12-20

75317 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75317

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-12-20

Regulatory Status

RX

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Drug Status Breakdown
73 total
  • Discontinued
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ALENDRONATE SODIUM

Application Number

90557

Product Number

1

Active Ingredient

ALENDRONATE SODIUM

Dosage Form

-

Strength

EQ 5MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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