Barr Laboratories Inc. RX
FDA Approved Drugs

Barr Laboratories Inc. RX

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
  • Total Records 87
  • Latest Approval Date Jan 27, 2022
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
269
View
Unclassified
16
View
Discontinued
165
View
OTC
1
View
RX
87
View
Company Overview

Company

Barr Laboratories Inc. RX

Country

U.S.A

Website

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Company Snapshot

Barr Laboratories Inc. RX

225 Summit Ave, Montvale, NJ 07645

U.S.A

www.barrlabs.com View on Map
FDA Approved Drug Records ( 87 records )
2013
04 Apr
RX Application: 91455

Drug Name

ACITRETIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2013-04-04

91455 / 1

Active Ingredient

ACITRETIN

Application Number

91455

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2013-04-04

Regulatory Status

RX

2013
04 Apr
RX Application: 91455

Drug Name

ACITRETIN

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2013-04-04

91455 / 2

Active Ingredient

ACITRETIN

Application Number

91455

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2013-04-04

Regulatory Status

RX

1988
10 May
RX Application: 71111

Drug Name

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG ANHYDROUS;50MG

Approval Date

1988-05-10

71111 / 1

Active Ingredient

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

71111

Product Number

1

Dosage Form

-

Strength

EQ 5MG ANHYDROUS;50MG

Approval Date

1988-05-10

Regulatory Status

RX

2004
29 Sep
RX Application: 76783

Drug Name

ARANELLE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2004-09-29

76783 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

76783

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2004-09-29

Regulatory Status

RX

2009
14 Aug
RX Application: 78804

Drug Name

ASPIRIN AND DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2009-08-14

78804 / 1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

78804

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2009-08-14

Regulatory Status

RX

2004
22 Apr
RX Application: 76238

Drug Name

BALZIVA-28

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2004-04-22

76238 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

76238

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2004-04-22

Regulatory Status

RX

1982
01 Jan
RX Application: 83116

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

83116 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

83116

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84768

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

84768 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84768

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84769

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84769 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84769

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

2005
10 Aug
RX Application: 77194

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2005-08-10

77194 / 1

Active Ingredient

CLONAZEPAM

Application Number

77194

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2005-08-10

Regulatory Status

RX

2005
10 Aug
RX Application: 77194

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2005-08-10

77194 / 2

Active Ingredient

CLONAZEPAM

Application Number

77194

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2005-08-10

Regulatory Status

RX

2005
10 Aug
RX Application: 77194

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2005-08-10

77194 / 3

Active Ingredient

CLONAZEPAM

Application Number

77194

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2005-08-10

Regulatory Status

RX

2005
10 Aug
RX Application: 77194

Drug Name

CLONAZEPAM

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2005-08-10

77194 / 4

Active Ingredient

CLONAZEPAM

Application Number

77194

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2005-08-10

Regulatory Status

RX

2005
10 Aug
RX Application: 77194

Drug Name

CLONAZEPAM

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2005-08-10

77194 / 5

Active Ingredient

CLONAZEPAM

Application Number

77194

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2005-08-10

Regulatory Status

RX

2015
25 Nov
RX Application: 90308

Drug Name

CLOZAPINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2015-11-25

90308 / 1

Active Ingredient

CLOZAPINE

Application Number

90308

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2015-11-25

Regulatory Status

RX

2015
25 Nov
RX Application: 90308

Drug Name

CLOZAPINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-11-25

90308 / 2

Active Ingredient

CLOZAPINE

Application Number

90308

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-11-25

Regulatory Status

RX

2018
09 Apr
RX Application: 90308

Drug Name

CLOZAPINE

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2018-04-09

90308 / 3

Active Ingredient

CLOZAPINE

Application Number

90308

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2018-04-09

Regulatory Status

RX

2015
25 Nov
RX Application: 90308

Drug Name

CLOZAPINE

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

2015-11-25

90308 / 4

Active Ingredient

CLOZAPINE

Application Number

90308

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

2015-11-25

Regulatory Status

RX

2015
25 Nov
RX Application: 90308

Drug Name

CLOZAPINE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2015-11-25

90308 / 5

Active Ingredient

CLOZAPINE

Application Number

90308

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2015-11-25

Regulatory Status

RX

1996
09 Aug
RX Application: 74582

Drug Name

DANAZOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-08-09

74582 / 1

Active Ingredient

DANAZOL

Application Number

74582

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-08-09

Regulatory Status

RX

1998
29 May
RX Application: 74582

Drug Name

DANAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1998-05-29

74582 / 2

Active Ingredient

DANAZOL

Application Number

74582

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1998-05-29

Regulatory Status

RX

1998
29 May
RX Application: 74582

Drug Name

DANAZOL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1998-05-29

74582 / 3

Active Ingredient

DANAZOL

Application Number

74582

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1998-05-29

Regulatory Status

RX

2002
11 Feb
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-02-11

40422 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-02-11

Regulatory Status

RX

2002
11 Feb
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2002-02-11

40422 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2002-02-11

Regulatory Status

RX

2002
11 Feb
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2002-02-11

40422 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

3

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2002-02-11

Regulatory Status

RX

2002
11 Feb
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2002-02-11

40422 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

4

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2002-02-11

Regulatory Status

RX

2003
19 Mar
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2003-03-19

40422 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

5

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2003-03-19

Regulatory Status

RX

2003
19 Mar
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2003-03-19

40422 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

6

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2003-03-19

Regulatory Status

RX

2003
19 Mar
RX Application: 40422

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

7

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2003-03-19

40422 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40422

Product Number

7

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2003-03-19

Regulatory Status

RX

2001
31 Jan
RX Application: 40361

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-01-31

40361 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

40361

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-01-31

Regulatory Status

RX

2001
31 Jan
RX Application: 40361

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-01-31

40361 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

40361

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-01-31

Regulatory Status

RX

1990
03 Oct
RX Application: 87184

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1990-10-03

87184 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

87184

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1990-10-03

Regulatory Status

RX

1990
03 Oct
RX Application: 87716

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1990-10-03

87716 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

87716

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1990-10-03

Regulatory Status

RX

2010
21 Dec
RX Application: 90095

Drug Name

DUTASTERIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2010-12-21

90095 / 1

Active Ingredient

DUTASTERIDE

Application Number

90095

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2010-12-21

Regulatory Status

RX

1997
22 Oct
RX Application: 40197

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1997-10-22

40197 / 1

Active Ingredient

ESTRADIOL

Application Number

40197

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1997-10-22

Regulatory Status

RX

1997
22 Oct
RX Application: 40197

Drug Name

ESTRADIOL

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1997-10-22

40197 / 2

Active Ingredient

ESTRADIOL

Application Number

40197

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1997-10-22

Regulatory Status

RX

1997
22 Oct
RX Application: 40197

Drug Name

ESTRADIOL

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1997-10-22

40197 / 3

Active Ingredient

ESTRADIOL

Application Number

40197

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1997-10-22

Regulatory Status

RX

2010
11 May
RX Application: 79193

Drug Name

ESTRADIOL AND NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

1MG;0.5MG

Approval Date

2010-05-11

79193 / 1

Active Ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Application Number

79193

Product Number

1

Dosage Form

-

Strength

1MG;0.5MG

Approval Date

2010-05-11

Regulatory Status

RX

2008
28 Aug
RX Application: 77605

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2008-08-28

77605 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77605

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2008-08-28

Regulatory Status

RX

2008
28 Aug
RX Application: 77605

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2008-08-28

77605 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77605

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2008-08-28

Regulatory Status

RX

2008
28 Aug
RX Application: 77605

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2008-08-28

77605 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77605

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2008-08-28

Regulatory Status

RX

2008
15 Sep
RX Application: 78189

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2008-09-15

78189 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78189

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2008-09-15

Regulatory Status

RX

2008
15 Sep
RX Application: 78189

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE

Approval Date

2008-09-15

78189 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78189

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE

Approval Date

2008-09-15

Regulatory Status

RX

2008
15 Sep
RX Application: 78189

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2008-09-15

78189 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78189

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2008-09-15

Regulatory Status

RX

1998
16 Oct
RX Application: 75143

Drug Name

HYDROXYUREA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1998-10-16

75143 / 1

Active Ingredient

HYDROXYUREA

Application Number

75143

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1998-10-16

Regulatory Status

RX

1984
15 Jun
RX Application: 88496

Drug Name

HYDROXYZINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1984-06-15

88496 / 1

Active Ingredient

HYDROXYZINE PAMOATE

Application Number

88496

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE

Approval Date

1984-06-15

Regulatory Status

RX

2003
30 May
RX Application: 76381

Drug Name

JUNEL 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2003-05-30

76381 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

76381

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2003-05-30

Regulatory Status

RX

2003
18 Sep
RX Application: 76064

Drug Name

JUNEL FE 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2003-09-18

76064 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

76064

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2003-09-18

Regulatory Status

RX

2003
18 Sep
RX Application: 76081

Drug Name

JUNEL FE 1/20

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2003-09-18

76081 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

76081

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2003-09-18

Regulatory Status

RX

2002
05 Apr
RX Application: 75863

Drug Name

KARIVA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-04-05

75863 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

75863

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-04-05

Regulatory Status

RX

2005
23 May
RX Application: 76785

Drug Name

KELNOR

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2005-05-23

76785 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Application Number

76785

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2005-05-23

Regulatory Status

RX

2022
27 Jan
RX Application: 90977

Drug Name

LANTHANUM CARBONATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2022-01-27

90977 / 1

Active Ingredient

LANTHANUM CARBONATE

Application Number

90977

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2022-01-27

Regulatory Status

RX

2022
27 Jan
RX Application: 90977

Drug Name

LANTHANUM CARBONATE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2022-01-27

90977 / 2

Active Ingredient

LANTHANUM CARBONATE

Application Number

90977

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2022-01-27

Regulatory Status

RX

2022
27 Jan
RX Application: 90977

Drug Name

LANTHANUM CARBONATE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2022-01-27

90977 / 3

Active Ingredient

LANTHANUM CARBONATE

Application Number

90977

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2022-01-27

Regulatory Status

RX

2002
20 Mar
RX Application: 75803

Drug Name

LESSINA-28

Product Number

2

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2002-03-20

75803 / 2

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

75803

Product Number

2

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2002-03-20

Regulatory Status

RX

1987
24 Sep
RX Application: 71198

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1987-09-24

71198 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

71198

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1987-09-24

Regulatory Status

RX

1987
24 Sep
RX Application: 71199

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1987-09-24

71199 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

71199

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1987-09-24

Regulatory Status

RX

1996
09 Aug
RX Application: 40159

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1996-08-09

40159 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

40159

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1996-08-09

Regulatory Status

RX

1996
09 Aug
RX Application: 40159

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1996-08-09

40159 / 2

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

40159

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1996-08-09

Regulatory Status

RX

1996
09 Aug
RX Application: 40159

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1996-08-09

40159 / 3

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

40159

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1996-08-09

Regulatory Status

RX

2003
29 Dec
RX Application: 76392

Drug Name

MEFLOQUINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2003-12-29

76392 / 1

Active Ingredient

MEFLOQUINE HYDROCHLORIDE

Application Number

76392

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2003-12-29

Regulatory Status

RX

1995
30 Nov
RX Application: 74621

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1995-11-30

74621 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

74621

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1995-11-30

Regulatory Status

RX

1996
16 Aug
RX Application: 74621

Drug Name

MEGESTROL ACETATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1996-08-16

74621 / 2

Active Ingredient

MEGESTROL ACETATE

Application Number

74621

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1996-08-16

Regulatory Status

RX

1990
15 Oct
RX Application: 81099

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

1990-10-15

81099 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

81099

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

1990-10-15

Regulatory Status

RX

1998
08 May
RX Application: 74918

Drug Name

NALTREXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-05-08

74918 / 1

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

74918

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-05-08

Regulatory Status

RX

2005
14 Apr
RX Application: 76250

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2005-04-14

76250 / 1

Active Ingredient

NIACIN

Application Number

76250

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2005-04-14

Regulatory Status

RX

2005
26 Apr
RX Application: 76378

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-04-26

76378 / 1

Active Ingredient

NIACIN

Application Number

76378

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-04-26

Regulatory Status

RX

2005
26 Apr
RX Application: 76378

Drug Name

NIACIN

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2005-04-26

76378 / 2

Active Ingredient

NIACIN

Application Number

76378

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2005-04-26

Regulatory Status

RX

2001
25 May
RX Application: 75951

Drug Name

NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-05-25

75951 / 1

Active Ingredient

NORETHINDRONE ACETATE

Application Number

75951

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-05-25

Regulatory Status

RX

2009
06 Nov
RX Application: 76221

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.005MG;1MG

Approval Date

2009-11-06

76221 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

76221

Product Number

1

Dosage Form

-

Strength

0.005MG;1MG

Approval Date

2009-11-06

Regulatory Status

RX

2010
05 Aug
RX Application: 78965

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2010-08-05

78965 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

78965

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2010-08-05

Regulatory Status

RX

1992
28 Feb
RX Application: 72693

Drug Name

NORTREL 1/35-21

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

1992-02-28

72693 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

72693

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

1992-02-28

Regulatory Status

RX

2002
30 Aug
RX Application: 75478

Drug Name

NORTREL 7/7/7

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-08-30

75478 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

75478

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-08-30

Regulatory Status

RX

2002
30 Aug
RX Application: 75478

Drug Name

NORTREL 7/7/7

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-08-30

75478 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

75478

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-08-30

Regulatory Status

RX

2012
30 Jan
RX Application: 77243

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-01-30

77243 / 1

Active Ingredient

OLANZAPINE

Application Number

77243

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-01-30

Regulatory Status

RX

2012
30 Jan
RX Application: 77243

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-01-30

77243 / 2

Active Ingredient

OLANZAPINE

Application Number

77243

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-01-30

Regulatory Status

RX

2012
30 Jan
RX Application: 77243

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2012-01-30

77243 / 3

Active Ingredient

OLANZAPINE

Application Number

77243

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2012-01-30

Regulatory Status

RX

2012
30 Jan
RX Application: 77243

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-01-30

77243 / 4

Active Ingredient

OLANZAPINE

Application Number

77243

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-01-30

Regulatory Status

RX

2002
23 May
RX Application: 75866

Drug Name

PORTIA-28

Product Number

2

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2002-05-23

75866 / 2

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

75866

Product Number

2

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2002-05-23

Regulatory Status

RX

2002
25 Sep
RX Application: 75804

Drug Name

SPRINTEC

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2002-09-25

75804 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

75804

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2002-09-25

Regulatory Status

RX

2001
21 Mar
RX Application: 40385

Drug Name

TREXALL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2001-03-21

40385 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

40385

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2001-03-21

Regulatory Status

RX

2001
21 Mar
RX Application: 40385

Drug Name

TREXALL

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2001-03-21

40385 / 2

Active Ingredient

METHOTREXATE SODIUM

Application Number

40385

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2001-03-21

Regulatory Status

RX

2001
21 Mar
RX Application: 40385

Drug Name

TREXALL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2001-03-21

40385 / 3

Active Ingredient

METHOTREXATE SODIUM

Application Number

40385

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2001-03-21

Regulatory Status

RX

2001
21 Mar
RX Application: 40385

Drug Name

TREXALL

Product Number

4

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2001-03-21

40385 / 4

Active Ingredient

METHOTREXATE SODIUM

Application Number

40385

Product Number

4

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2001-03-21

Regulatory Status

RX

2009
29 Jun
RX Application: 76784

Drug Name

TRI LO SPRINTEC

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-06-29

76784 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

76784

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-06-29

Regulatory Status

RX

2007
26 Oct
RX Application: 76105

Drug Name

TRI-LEGEST FE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2007-10-26

76105 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

76105

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2007-10-26

Regulatory Status

RX

2003
29 Dec
RX Application: 75808

Drug Name

TRI-SPRINTEC

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2003-12-29

75808 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

75808

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2003-12-29

Regulatory Status

RX

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Drug Status Breakdown
87 total
  • RX
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

ACITRETIN

Application Number

91455

Product Number

1

Active Ingredient

ACITRETIN

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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