Ipca Laboratories
FDA Approved Drugs

Ipca Laboratories

FDA Approved Drugs Database

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

RX Discontinued
  • Total Records 87
  • Latest Approval Date May 01, 2026
  • Data Source FDA
  • First Approval Date Sep 18, 2006
All
87
View
Discontinued
36
View
RX
51
View
Company Overview

Company

Ipca Laboratories

Country

India

Website

Visit Website

Email

swapna.ugale@ipca.com

Social Profiles

LinkedIn
Company Snapshot

Ipca Laboratories

Kandivli (West), Mumbai – 400 067, Maharashtra

India

www.ipca.com/ swapna.ugale@ipca.com View on Map
FDA Approved Drug Records ( 87 records )
2024
04 Jun
RX Application: 206387

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-06-04

206387 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

206387

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-06-04

Regulatory Status

RX

2024
04 Jun
RX Application: 206387

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2024-06-04

206387 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

206387

Product Number

2

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2024-06-04

Regulatory Status

RX

2024
04 Jun
RX Application: 206387

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-06-04

206387 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

206387

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2024-06-04

Regulatory Status

RX

2024
04 Jun
RX Application: 206387

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2024-06-04

206387 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

206387

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2024-06-04

Regulatory Status

RX

2011
16 Mar
Discontinued Application: 90637

Drug Name

ALLOPURINOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-03-16

90637 / 1

Active Ingredient

ALLOPURINOL

Application Number

90637

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-03-16

Regulatory Status

Discontinued

2011
16 Mar
Discontinued Application: 90637

Drug Name

ALLOPURINOL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2011-03-16

90637 / 2

Active Ingredient

ALLOPURINOL

Application Number

90637

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2011-03-16

Regulatory Status

Discontinued

2006
27 Dec
RX Application: 77877

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-12-27

77877 / 1

Active Ingredient

ATENOLOL

Application Number

77877

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-12-27

Regulatory Status

RX

2006
27 Dec
RX Application: 77877

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-12-27

77877 / 2

Active Ingredient

ATENOLOL

Application Number

77877

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-12-27

Regulatory Status

RX

2006
27 Dec
RX Application: 77877

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-12-27

77877 / 3

Active Ingredient

ATENOLOL

Application Number

77877

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-12-27

Regulatory Status

RX

2025
02 May
RX Application: 207874

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-05-02

207874 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207874

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-05-02

Regulatory Status

RX

2025
02 May
RX Application: 207874

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2025-05-02

207874 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207874

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2025-05-02

Regulatory Status

RX

2025
02 May
RX Application: 207874

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2025-05-02

207874 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

207874

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2025-05-02

Regulatory Status

RX

2009
03 Dec
Discontinued Application: 90249

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-12-03

90249 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

90249

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-12-03

Regulatory Status

Discontinued

2009
03 Dec
Discontinued Application: 90610

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-12-03

90610 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

90610

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-12-03

Regulatory Status

Discontinued

2024
12 Nov
RX Application: 209162

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-11-12

209162 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

209162

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-11-12

Regulatory Status

RX

2024
12 Nov
RX Application: 209162

Drug Name

CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-11-12

209162 / 2

Active Ingredient

CHLORTHALIDONE

Application Number

209162

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-11-12

Regulatory Status

RX

2023
29 Dec
Discontinued Application: 206222

Drug Name

ESZOPICLONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-12-29

206222 / 1

Active Ingredient

ESZOPICLONE

Application Number

206222

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-12-29

Regulatory Status

Discontinued

2023
29 Dec
Discontinued Application: 206222

Drug Name

ESZOPICLONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2023-12-29

206222 / 2

Active Ingredient

ESZOPICLONE

Application Number

206222

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2023-12-29

Regulatory Status

Discontinued

2023
29 Dec
Discontinued Application: 206222

Drug Name

ESZOPICLONE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2023-12-29

206222 / 3

Active Ingredient

ESZOPICLONE

Application Number

206222

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2023-12-29

Regulatory Status

Discontinued

2024
01 May
RX Application: 204729

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2024-05-01

204729 / 1

Active Ingredient

ETODOLAC

Application Number

204729

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2024-05-01

Regulatory Status

RX

2024
01 May
RX Application: 204729

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-05-01

204729 / 2

Active Ingredient

ETODOLAC

Application Number

204729

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-05-01

Regulatory Status

RX

2024
01 Aug
RX Application: 205448

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-08-01

205448 / 1

Active Ingredient

ETODOLAC

Application Number

205448

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-08-01

Regulatory Status

RX

2024
01 Aug
RX Application: 205448

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-08-01

205448 / 2

Active Ingredient

ETODOLAC

Application Number

205448

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-08-01

Regulatory Status

RX

2006
18 Sep
RX Application: 78010

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2006-09-18

78010 / 1

Active Ingredient

FUROSEMIDE

Application Number

78010

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2006-09-18

Regulatory Status

RX

2006
18 Sep
RX Application: 78010

Drug Name

FUROSEMIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2006-09-18

78010 / 2

Active Ingredient

FUROSEMIDE

Application Number

78010

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2006-09-18

Regulatory Status

RX

2006
18 Sep
RX Application: 78010

Drug Name

FUROSEMIDE

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2006-09-18

78010 / 3

Active Ingredient

FUROSEMIDE

Application Number

78010

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2006-09-18

Regulatory Status

RX

2023
20 Nov
Discontinued Application: 208928

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2023-11-20

208928 / 1

Active Ingredient

GABAPENTIN

Application Number

208928

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2023-11-20

Regulatory Status

Discontinued

2023
20 Nov
Discontinued Application: 208928

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2023-11-20

208928 / 2

Active Ingredient

GABAPENTIN

Application Number

208928

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2023-11-20

Regulatory Status

Discontinued

2023
20 Nov
Discontinued Application: 208928

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2023-11-20

208928 / 3

Active Ingredient

GABAPENTIN

Application Number

208928

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2023-11-20

Regulatory Status

Discontinued

2024
29 May
Discontinued Application: 209855

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2024-05-29

209855 / 1

Active Ingredient

GABAPENTIN

Application Number

209855

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2024-05-29

Regulatory Status

Discontinued

2024
29 May
Discontinued Application: 209855

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2024-05-29

209855 / 2

Active Ingredient

GABAPENTIN

Application Number

209855

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2024-05-29

Regulatory Status

Discontinued

2007
20 Jul
Discontinued Application: 40807

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2007-07-20

40807 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40807

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2007-07-20

Regulatory Status

Discontinued

2007
20 Jul
Discontinued Application: 40807

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2007-07-20

40807 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40807

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2007-07-20

Regulatory Status

Discontinued

2007
20 Jul
Discontinued Application: 40807

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2007-07-20

40807 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40807

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2007-07-20

Regulatory Status

Discontinued

2009
02 Apr
Discontinued Application: 79237

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-04-02

79237 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

79237

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-04-02

Regulatory Status

Discontinued

2007
14 Jun
RX Application: 40766

Drug Name

HYDROXYCHLOROQUINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2007-06-14

40766 / 1

Active Ingredient

HYDROXYCHLOROQUINE SULFATE

Application Number

40766

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2007-06-14

Regulatory Status

RX

2024
22 May
Discontinued Application: 211056

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2024-05-22

211056 / 1

Active Ingredient

IRBESARTAN

Application Number

211056

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2024-05-22

Regulatory Status

Discontinued

2024
22 May
Discontinued Application: 211056

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2024-05-22

211056 / 2

Active Ingredient

IRBESARTAN

Application Number

211056

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2024-05-22

Regulatory Status

Discontinued

2024
22 May
Discontinued Application: 211056

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2024-05-22

211056 / 3

Active Ingredient

IRBESARTAN

Application Number

211056

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2024-05-22

Regulatory Status

Discontinued

2024
06 May
Discontinued Application: 204626

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-05-06

204626 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

204626

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-05-06

Regulatory Status

Discontinued

2013
30 Aug
Discontinued Application: 200290

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-08-30

200290 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

200290

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-08-30

Regulatory Status

Discontinued

2013
30 Aug
Discontinued Application: 200290

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-08-30

200290 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

200290

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-08-30

Regulatory Status

Discontinued

2013
30 Aug
Discontinued Application: 200290

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-08-30

200290 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

200290

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-08-30

Regulatory Status

Discontinued

2013
01 Mar
Discontinued Application: 201682

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2013-03-01

201682 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

201682

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2013-03-01

Regulatory Status

Discontinued

2013
01 Mar
Discontinued Application: 201682

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2013-03-01

201682 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

201682

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2013-03-01

Regulatory Status

Discontinued

2013
01 Mar
Discontinued Application: 201682

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2013-03-01

201682 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

201682

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2013-03-01

Regulatory Status

Discontinued

2007
06 Aug
Discontinued Application: 78422

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2007-08-06

78422 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

78422

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2007-08-06

Regulatory Status

Discontinued

2007
06 Aug
Discontinued Application: 78422

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2007-08-06

78422 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

78422

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2007-08-06

Regulatory Status

Discontinued

2007
06 Aug
Discontinued Application: 78422

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2007-08-06

78422 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

78422

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2007-08-06

Regulatory Status

Discontinued

2008
12 Jun
RX Application: 78807

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-06-12

78807 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

78807

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-06-12

Regulatory Status

RX

2008
12 Jun
RX Application: 78807

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-06-12

78807 / 2

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

78807

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-06-12

Regulatory Status

RX

2025
25 Jun
RX Application: 206980

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2025-06-25

206980 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

206980

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2025-06-25

Regulatory Status

RX

2025
25 Jun
RX Application: 206980

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2025-06-25

206980 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

206980

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2025-06-25

Regulatory Status

RX

2025
25 Jun
RX Application: 206980

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2025-06-25

206980 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

206980

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2025-06-25

Regulatory Status

RX

2025
25 Jun
RX Application: 206980

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2025-06-25

206980 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

206980

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2025-06-25

Regulatory Status

RX

2008
17 Jun
RX Application: 78459

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-06-17

78459 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

78459

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-06-17

Regulatory Status

RX

2008
17 Jun
RX Application: 78459

Drug Name

METOPROLOL TARTRATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-06-17

78459 / 2

Active Ingredient

METOPROLOL TARTRATE

Application Number

78459

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-06-17

Regulatory Status

RX

2008
17 Jun
RX Application: 78459

Drug Name

METOPROLOL TARTRATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2008-06-17

78459 / 3

Active Ingredient

METOPROLOL TARTRATE

Application Number

78459

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2008-06-17

Regulatory Status

RX

2023
30 Oct
RX Application: 209389

Drug Name

ONDANSETRON

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2023-10-30

209389 / 1

Active Ingredient

ONDANSETRON

Application Number

209389

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2023-10-30

Regulatory Status

RX

2023
30 Oct
RX Application: 209389

Drug Name

ONDANSETRON

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2023-10-30

209389 / 2

Active Ingredient

ONDANSETRON

Application Number

209389

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2023-10-30

Regulatory Status

RX

2014
23 Jan
RX Application: 203761

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2014-01-23

203761 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

203761

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2014-01-23

Regulatory Status

RX

2014
23 Jan
RX Application: 203761

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2014-01-23

203761 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

203761

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2014-01-23

Regulatory Status

RX

2008
02 Jun
RX Application: 78955

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2008-06-02

78955 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78955

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2008-06-02

Regulatory Status

RX

2008
02 Jun
RX Application: 78955

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2008-06-02

78955 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78955

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2008-06-02

Regulatory Status

RX

2008
02 Jun
RX Application: 78955

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2008-06-02

78955 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78955

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2008-06-02

Regulatory Status

RX

2008
02 Jun
RX Application: 78955

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2008-06-02

78955 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78955

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2008-06-02

Regulatory Status

RX

2008
02 Jun
RX Application: 78955

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2008-06-02

78955 / 5

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78955

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2008-06-02

Regulatory Status

RX

2026
01 May
RX Application: 203103

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-05-01

203103 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

203103

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2026-05-01

Regulatory Status

RX

2026
01 May
RX Application: 203103

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2026-05-01

203103 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

203103

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2026-05-01

Regulatory Status

RX

2026
01 May
RX Application: 203103

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2026-05-01

203103 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

203103

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2026-05-01

Regulatory Status

RX

2026
01 May
RX Application: 203103

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2026-05-01

203103 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

203103

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2026-05-01

Regulatory Status

RX

2024
20 May
Discontinued Application: 205983

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-05-20

205983 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

205983

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-05-20

Regulatory Status

Discontinued

2024
20 May
Discontinued Application: 205983

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-05-20

205983 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

205983

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-05-20

Regulatory Status

Discontinued

2024
20 May
Discontinued Application: 205983

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-05-20

205983 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

205983

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-05-20

Regulatory Status

Discontinued

2024
20 May
Discontinued Application: 205983

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2024-05-20

205983 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

205983

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2024-05-20

Regulatory Status

Discontinued

2024
20 May
Discontinued Application: 205983

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2024-05-20

205983 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

205983

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2024-05-20

Regulatory Status

Discontinued

2024
20 May
Discontinued Application: 205983

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2024-05-20

205983 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

205983

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2024-05-20

Regulatory Status

Discontinued

2024
26 Jun
RX Application: 205104

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2024-06-26

205104 / 1

Active Ingredient

RISPERIDONE

Application Number

205104

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 205104

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2024-06-26

205104 / 2

Active Ingredient

RISPERIDONE

Application Number

205104

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 205104

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2024-06-26

205104 / 3

Active Ingredient

RISPERIDONE

Application Number

205104

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 205104

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2024-06-26

205104 / 4

Active Ingredient

RISPERIDONE

Application Number

205104

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 205104

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2024-06-26

205104 / 5

Active Ingredient

RISPERIDONE

Application Number

205104

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 205104

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2024-06-26

205104 / 6

Active Ingredient

RISPERIDONE

Application Number

205104

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2024-06-26

Regulatory Status

RX

2025
15 Jul
RX Application: 206019

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2025-07-15

206019 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

206019

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2025-07-15

Regulatory Status

RX

2025
15 Jul
RX Application: 206019

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-07-15

206019 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

206019

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-07-15

Regulatory Status

RX

2025
15 Jul
RX Application: 206019

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2025-07-15

206019 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

206019

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2025-07-15

Regulatory Status

RX

2012
16 Nov
Discontinued Application: 201973

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2012-11-16

201973 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

201973

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2012-11-16

Regulatory Status

Discontinued

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Drug Status Breakdown
87 total
  • RX
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ALENDRONATE SODIUM

Application Number

206387

Product Number

1

Active Ingredient

ALENDRONATE SODIUM

Dosage Form

-

Strength

EQ 10MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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