Pliva Hrvatska
FDA Approved Drugs

Pliva Hrvatska

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 Unclassified RX
  • Total Records 125
  • Latest Approval Date Mar 30, 2009
  • Data Source FDA
  • First Approval Date Jul 26, 1983
All
125
View
Unclassified
3
View
Discontinued
92
View
RX
30
View
Company Overview

Company

Pliva Hrvatska

Country

Croatia

Website

Visit Website

Email

tamara.susanj-sulentic@pliva.hr

Social Profiles

Company Snapshot

Pliva Hrvatska

PLIVA HRVATSKA d.o.o.Prilaz baruna Filipovića 2510000 Zagreb, Croatia

Croatia

www.pliva.com/ tamara.susanj-sulentic@pliva.hr View on Map
FDA Approved Drug Records ( 125 records )
1996
01 Aug
Discontinued Application: 74072

Drug Name

ALBUTEROL

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1996-08-01

74072 / 1

Active Ingredient

ALBUTEROL

Application Number

74072

Product Number

1

Dosage Form

-

Strength

0.09MG/INH

Approval Date

1996-08-01

Regulatory Status

Discontinued

1989
05 Dec
Discontinued Application: 72316

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1989-12-05

72316 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72316

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1989-12-05

Regulatory Status

Discontinued

1989
05 Dec
Discontinued Application: 72317

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1989-12-05

72317 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

72317

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1989-12-05

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88883

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-09-26

88883 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

88883

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88884

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-09-26

88884 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

88884

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88885

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-09-26

88885 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

88885

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88886

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1984-09-26

88886 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

88886

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88887

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-09-26

88887 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

88887

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

1984
26 Sep
Discontinued Application: 88888

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1984-09-26

88888 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

88888

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1984-09-26

Regulatory Status

Discontinued

-
Unclassified Application: 79238

Drug Name

ARGATROBAN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

79238 / 1

Active Ingredient

ARGATROBAN

Application Number

79238

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

1997
17 Jul
Discontinued Application: 74101

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-07-17

74101 / 1

Active Ingredient

ATENOLOL

Application Number

74101

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1997-07-17

Regulatory Status

Discontinued

1997
17 Jul
Discontinued Application: 74101

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-07-17

74101 / 2

Active Ingredient

ATENOLOL

Application Number

74101

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1997-07-17

Regulatory Status

Discontinued

1997
17 Jul
Discontinued Application: 74101

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1997-07-17

74101 / 3

Active Ingredient

ATENOLOL

Application Number

74101

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1997-07-17

Regulatory Status

Discontinued

1997
24 Sep
Discontinued Application: 74107

Drug Name

ATENOLOL AND CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

50MG;25MG

Approval Date

1997-09-24

74107 / 1

Active Ingredient

ATENOLOL; CHLORTHALIDONE

Application Number

74107

Product Number

1

Dosage Form

-

Strength

50MG;25MG

Approval Date

1997-09-24

Regulatory Status

Discontinued

1997
24 Sep
Discontinued Application: 74107

Drug Name

ATENOLOL AND CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

1997-09-24

74107 / 2

Active Ingredient

ATENOLOL; CHLORTHALIDONE

Application Number

74107

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

1997-09-24

Regulatory Status

Discontinued

2005
14 Nov
RX Application: 65218

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

65218 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65218

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2005
14 Nov
RX Application: 65223

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

65223 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65223

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2005
14 Nov
RX Application: 65225

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

65225 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65225

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-11-14

Regulatory Status

RX

2006
05 Jul
RX Application: 65246

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2006-07-05

65246 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65246

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 65246

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2006-07-05

65246 / 2

Active Ingredient

AZITHROMYCIN

Application Number

65246

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2006-07-05

Regulatory Status

RX

1988
10 Aug
RX Application: 89058

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1988-08-10

89058 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

89058

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1988-08-10

Regulatory Status

RX

1988
10 Aug
RX Application: 89059

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1988-08-10

89059 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

89059

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1988-08-10

Regulatory Status

RX

1988
10 Aug
RX Application: 89060

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1988-08-10

89060 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

89060

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1988-08-10

Regulatory Status

RX

-
Unclassified Application: 91206

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

-

91206 / 1

Active Ingredient

BIVALIRUDIN

Application Number

91206

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

1987
24 Jul
Discontinued Application: 71479

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-07-24

71479 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

71479

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-07-24

Regulatory Status

Discontinued

2004
16 Nov
Discontinued Application: 76602

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2004-11-16

76602 / 1

Active Ingredient

CARBOPLATIN

Application Number

76602

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2004-11-16

Regulatory Status

Discontinued

2004
16 Nov
Discontinued Application: 76602

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2004-11-16

76602 / 2

Active Ingredient

CARBOPLATIN

Application Number

76602

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2004-11-16

Regulatory Status

Discontinued

2004
16 Nov
Discontinued Application: 76602

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2004-11-16

76602 / 3

Active Ingredient

CARBOPLATIN

Application Number

76602

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2004-11-16

Regulatory Status

Discontinued

2007
30 Oct
Discontinued Application: 78240

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-10-30

78240 / 1

Active Ingredient

CARVEDILOL

Application Number

78240

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-10-30

Regulatory Status

Discontinued

2007
30 Oct
Discontinued Application: 78240

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-10-30

78240 / 2

Active Ingredient

CARVEDILOL

Application Number

78240

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-10-30

Regulatory Status

Discontinued

2007
30 Oct
Discontinued Application: 78240

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-10-30

78240 / 3

Active Ingredient

CARVEDILOL

Application Number

78240

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-10-30

Regulatory Status

Discontinued

2007
30 Oct
Discontinued Application: 78240

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-10-30

78240 / 4

Active Ingredient

CARVEDILOL

Application Number

78240

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-10-30

Regulatory Status

Discontinued

2007
29 Oct
Discontinued Application: 77898

Drug Name

CILOSTAZOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2007-10-29

77898 / 1

Active Ingredient

CILOSTAZOL

Application Number

77898

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2007-10-29

Regulatory Status

Discontinued

2007
29 Oct
Discontinued Application: 77898

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2007-10-29

77898 / 2

Active Ingredient

CILOSTAZOL

Application Number

77898

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2007-10-29

Regulatory Status

Discontinued

1997
27 Feb
Discontinued Application: 74566

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1997-02-27

74566 / 1

Active Ingredient

CIMETIDINE

Application Number

74566

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1997-02-27

Regulatory Status

Discontinued

1997
27 Feb
Discontinued Application: 74568

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-02-27

74568 / 1

Active Ingredient

CIMETIDINE

Application Number

74568

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-02-27

Regulatory Status

Discontinued

1997
27 Feb
Discontinued Application: 74568

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-02-27

74568 / 2

Active Ingredient

CIMETIDINE

Application Number

74568

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-02-27

Regulatory Status

Discontinued

1997
27 Feb
Discontinued Application: 74568

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1997-02-27

74568 / 3

Active Ingredient

CIMETIDINE

Application Number

74568

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1997-02-27

Regulatory Status

Discontinued

2005
15 Jun
Discontinued Application: 76426

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-06-15

76426 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76426

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-06-15

Regulatory Status

Discontinued

2005
15 Jun
Discontinued Application: 76426

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-06-15

76426 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76426

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-06-15

Regulatory Status

Discontinued

2005
15 Jun
Discontinued Application: 76426

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2005-06-15

76426 / 4

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76426

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2005-06-15

Regulatory Status

Discontinued

1995
29 Sep
Discontinued Application: 74421

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1995-09-29

74421 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

74421

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1995-09-29

Regulatory Status

Discontinued

1983
26 Jul
Discontinued Application: 88205

Drug Name

CYPROHEPTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1983-07-26

88205 / 1

Active Ingredient

CYPROHEPTADINE HYDROCHLORIDE

Application Number

88205

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1983-07-26

Regulatory Status

Discontinued

1999
29 Jul
Discontinued Application: 74432

Drug Name

DICLOFENAC SODIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1999-07-29

74432 / 2

Active Ingredient

DICLOFENAC SODIUM

Application Number

74432

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1999-07-29

Regulatory Status

Discontinued

1999
29 Jul
Discontinued Application: 74432

Drug Name

DICLOFENAC SODIUM

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1999-07-29

74432 / 3

Active Ingredient

DICLOFENAC SODIUM

Application Number

74432

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1999-07-29

Regulatory Status

Discontinued

2001
08 Jun
Discontinued Application: 75750

Drug Name

DOXAZOSIN MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2001-06-08

75750 / 1

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75750

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2001-06-08

Regulatory Status

Discontinued

2001
08 Jun
Discontinued Application: 75750

Drug Name

DOXAZOSIN MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2001-06-08

75750 / 2

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75750

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2001-06-08

Regulatory Status

Discontinued

2001
08 Jun
Discontinued Application: 75750

Drug Name

DOXAZOSIN MESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2001-06-08

75750 / 3

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75750

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2001-06-08

Regulatory Status

Discontinued

2001
08 Jun
Discontinued Application: 75750

Drug Name

DOXAZOSIN MESYLATE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2001-06-08

75750 / 4

Active Ingredient

DOXAZOSIN MESYLATE

Application Number

75750

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2001-06-08

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 63187

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1992-06-30

63187 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

63187

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1992-06-30

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76424

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

76424 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76424

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76424

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

76424 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76424

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76424

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

76424 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76424

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76424

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

76424 / 4

Active Ingredient

FLUCONAZOLE

Application Number

76424

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

1997
01 Apr
Discontinued Application: 74647

Drug Name

FLURBIPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1997-04-01

74647 / 1

Active Ingredient

FLURBIPROFEN

Application Number

74647

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1997-04-01

Regulatory Status

Discontinued

1997
01 Apr
Discontinued Application: 74647

Drug Name

FLURBIPROFEN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-04-01

74647 / 2

Active Ingredient

FLURBIPROFEN

Application Number

74647

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-04-01

Regulatory Status

Discontinued

1984
01 May
RX Application: 88467

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-05-01

88467 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

88467

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1984-05-01

Regulatory Status

RX

1984
01 May
RX Application: 88468

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-05-01

88468 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

88468

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-05-01

Regulatory Status

RX

1985
18 Dec
RX Application: 89097

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-12-18

89097 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

89097

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1985-12-18

Regulatory Status

RX

1985
18 Dec
RX Application: 89098

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-12-18

89098 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

89098

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1985-12-18

Regulatory Status

RX

1995
25 Sep
Discontinued Application: 81054

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-09-25

81054 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

81054

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-09-25

Regulatory Status

Discontinued

1986
10 Jan
RX Application: 88617

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-01-10

88617 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88617

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1986-01-10

Regulatory Status

RX

1986
10 Jan
RX Application: 88618

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1986-01-10

88618 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88618

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1986-01-10

Regulatory Status

RX

1986
10 Jan
RX Application: 88619

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1986-01-10

88619 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88619

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1986-01-10

Regulatory Status

RX

1987
16 Jul
Discontinued Application: 71773

Drug Name

IBUPRIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-07-16

71773 / 1

Active Ingredient

IBUPROFEN

Application Number

71773

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-07-16

Regulatory Status

Discontinued

1987
18 Jun
Discontinued Application: 71666

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1987-06-18

71666 / 1

Active Ingredient

IBUPROFEN

Application Number

71666

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1987-06-18

Regulatory Status

Discontinued

1987
18 Jun
Discontinued Application: 71667

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1987-06-18

71667 / 1

Active Ingredient

IBUPROFEN

Application Number

71667

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1987-06-18

Regulatory Status

Discontinued

1987
18 Jun
Discontinued Application: 71668

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1987-06-18

71668 / 1

Active Ingredient

IBUPROFEN

Application Number

71668

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

1987-06-18

Regulatory Status

Discontinued

1999
23 Jun
Discontinued Application: 75284

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1999-06-23

75284 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75284

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1999-06-23

Regulatory Status

Discontinued

1985
11 Dec
Discontinued Application: 88733

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-12-11

88733 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

88733

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-12-11

Regulatory Status

Discontinued

1985
11 Dec
Discontinued Application: 88734

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-12-11

88734 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

88734

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1985-12-11

Regulatory Status

Discontinued

1988
07 Jul
Discontinued Application: 72126

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1988-07-07

72126 / 1

Active Ingredient

METHYLDOPA

Application Number

72126

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1988-07-07

Regulatory Status

Discontinued

1988
07 Jul
Discontinued Application: 72127

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1988-07-07

72127 / 1

Active Ingredient

METHYLDOPA

Application Number

72127

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1988-07-07

Regulatory Status

Discontinued

1988
07 Jul
Discontinued Application: 72128

Drug Name

METHYLDOPA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1988-07-07

72128 / 1

Active Ingredient

METHYLDOPA

Application Number

72128

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1988-07-07

Regulatory Status

Discontinued

1984
06 Dec
RX Application: 70033

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-12-06

70033 / 1

Active Ingredient

METRONIDAZOLE

Application Number

70033

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1984-12-06

Regulatory Status

RX

1996
27 Jun
Discontinued Application: 74182

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1996-06-27

74182 / 1

Active Ingredient

NAPROXEN

Application Number

74182

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1996-06-27

Regulatory Status

Discontinued

1996
27 Jun
Discontinued Application: 74182

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1996-06-27

74182 / 2

Active Ingredient

NAPROXEN

Application Number

74182

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1996-06-27

Regulatory Status

Discontinued

1996
27 Jun
Discontinued Application: 74182

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1996-06-27

74182 / 3

Active Ingredient

NAPROXEN

Application Number

74182

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1996-06-27

Regulatory Status

Discontinued

1999
26 May
Discontinued Application: 75337

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1999-05-26

75337 / 1

Active Ingredient

NAPROXEN

Application Number

75337

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

1999-05-26

Regulatory Status

Discontinued

1999
26 May
Discontinued Application: 75337

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-05-26

75337 / 2

Active Ingredient

NAPROXEN

Application Number

75337

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-05-26

Regulatory Status

Discontinued

1996
20 Jun
Discontinued Application: 74242

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1996-06-20

74242 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74242

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1996-06-20

Regulatory Status

Discontinued

1996
20 Jun
Discontinued Application: 74242

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-06-20

74242 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74242

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-06-20

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77112

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

77112 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77112

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77112

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

77112 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77112

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77112

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2007-06-25

77112 / 3

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77112

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 77544

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77544 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77544

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

1999
25 May
Discontinued Application: 74874

Drug Name

PENTOXIFYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-05-25

74874 / 1

Active Ingredient

PENTOXIFYLLINE

Application Number

74874

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1999-05-25

Regulatory Status

Discontinued

2006
21 Nov
Discontinued Application: 77730

Drug Name

PRAVASTATIN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-11-21

77730 / 1

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77730

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-11-21

Regulatory Status

Discontinued

2006
21 Nov
Discontinued Application: 77730

Drug Name

PRAVASTATIN SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-11-21

77730 / 2

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77730

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-11-21

Regulatory Status

Discontinued

2006
21 Nov
Discontinued Application: 77730

Drug Name

PRAVASTATIN SODIUM

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2006-11-21

77730 / 3

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77730

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2006-11-21

Regulatory Status

Discontinued

-
Unclassified Application: 77730

Drug Name

PRAVASTATIN SODIUM

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

-

77730 / 4

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77730

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

2006
21 Nov
Discontinued Application: 77730

Drug Name

PRAVASTATIN SODIUM

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2006-11-21

77730 / 5

Active Ingredient

PRAVASTATIN SODIUM

Application Number

77730

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2006-11-21

Regulatory Status

Discontinued

1985
10 Sep
Discontinued Application: 70215

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1985-09-10

70215 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70215

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985
10 Sep
Discontinued Application: 70216

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1985-09-10

70216 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70216

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1985-09-10

Regulatory Status

Discontinued

2009
30 Mar
Discontinued Application: 77905

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-30

77905 / 1

Active Ingredient

TOPIRAMATE

Application Number

77905

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-30

Regulatory Status

Discontinued

2009
30 Mar
Discontinued Application: 77905

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-30

77905 / 2

Active Ingredient

TOPIRAMATE

Application Number

77905

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-30

Regulatory Status

Discontinued

2009
30 Mar
Discontinued Application: 77905

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-30

77905 / 3

Active Ingredient

TOPIRAMATE

Application Number

77905

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-30

Regulatory Status

Discontinued

2009
30 Mar
Discontinued Application: 77905

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-30

77905 / 4

Active Ingredient

TOPIRAMATE

Application Number

77905

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-30

Regulatory Status

Discontinued

2003
30 May
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-05-30

76346 / 1

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-05-30

Regulatory Status

RX

2003
30 May
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-05-30

76346 / 2

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-05-30

Regulatory Status

RX

2003
30 May
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-05-30

76346 / 3

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-05-30

Regulatory Status

RX

2004
19 Oct
RX Application: 76346

Drug Name

TORSEMIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2004-10-19

76346 / 4

Active Ingredient

TORSEMIDE

Application Number

76346

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2004-10-19

Regulatory Status

RX

2002
01 Jul
Discontinued Application: 75982

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-01

75982 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75982

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

1988
09 Mar
RX Application: 71525

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1988-03-09

71525 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71525

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

1988-03-09

Regulatory Status

RX

1996
26 Apr
Discontinued Application: 74026

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1996-04-26

74026 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

74026

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1996-04-26

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 62645

Drug Name

ULTRAGRIS-165

Product Number

1

Dosage Form

-

Strength

165MG

Approval Date

1992-06-30

62645 / 1

Active Ingredient

GRISEOFULVIN, ULTRAMICROCRYSTALLINE

Application Number

62645

Product Number

1

Dosage Form

-

Strength

165MG

Approval Date

1992-06-30

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 62646

Drug Name

ULTRAGRIS-330

Product Number

1

Dosage Form

-

Strength

330MG

Approval Date

1992-06-30

62646 / 1

Active Ingredient

GRISEOFULVIN, ULTRAMICROCRYSTALLINE

Application Number

62646

Product Number

1

Dosage Form

-

Strength

330MG

Approval Date

1992-06-30

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 78517

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2008-06-13

78517 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78517

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 78517

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2008-06-13

78517 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78517

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 78517

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2008-06-13

78517 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78517

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 78517

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2008-06-13

78517 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78517

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2008-06-13

Regulatory Status

Discontinued

2008
13 Jun
Discontinued Application: 78517

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-06-13

78517 / 5

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78517

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-06-13

Regulatory Status

Discontinued

1989
26 Jan
Discontinued Application: 72124

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1989-01-26

72124 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

72124

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1989-01-26

Regulatory Status

Discontinued

1989
26 Jan
Discontinued Application: 72125

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1989-01-26

72125 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

72125

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1989-01-26

Regulatory Status

Discontinued

1996
23 Feb
Discontinued Application: 72751

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1996-02-23

72751 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

72751

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1996-02-23

Regulatory Status

Discontinued

1996
01 Mar
Discontinued Application: 72922

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

1996-03-01

72922 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

72922

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

1996-03-01

Regulatory Status

Discontinued

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2006-07-05

40616 / 1

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2006-07-05

40616 / 2

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2006-07-05

40616 / 3

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2006-07-05

40616 / 4

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2006-07-05

40616 / 5

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

6

Dosage Form

-

Strength

6MG

Approval Date

2006-07-05

40616 / 6

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

6

Dosage Form

-

Strength

6MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

7

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-05

40616 / 7

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

7

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

8

Dosage Form

-

Strength

10MG

Approval Date

2006-07-05

40616 / 8

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

8

Dosage Form

-

Strength

10MG

Approval Date

2006-07-05

Regulatory Status

RX

2006
05 Jul
RX Application: 40616

Drug Name

WARFARIN SODIUM

Product Number

9

Dosage Form

-

Strength

1MG

Approval Date

2006-07-05

40616 / 9

Active Ingredient

WARFARIN SODIUM

Application Number

40616

Product Number

9

Dosage Form

-

Strength

1MG

Approval Date

2006-07-05

Regulatory Status

RX

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Drug Status Breakdown
125 total
  • Discontinued
  • Unclassified
  • 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

ALBUTEROL

Application Number

74072

Product Number

1

Active Ingredient

ALBUTEROL

Dosage Form

-

Strength

0.09MG/INH

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Organized FDA drug records

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