Fresenius Kabi USA RX
FDA Approved Drugs

Fresenius Kabi USA 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 417
  • Latest Approval Date Aug 04, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
581
View
Unclassified
18
View
Discontinued
146
View
RX
417
View
Company Overview

Company

Fresenius Kabi USA RX

Country

U.S.A

Website

Visit Website

Email

contactus@fresenius-kabi.com

Social Profiles

Company Snapshot

Fresenius Kabi USA RX

Three Corporate DriveLake Zurich, Illinois 60047

U.S.A

www.fresenius-kabi.com/us/ contactus@fresenius-kabi.com View on Map
FDA Approved Drug Records ( 417 records )
2015
28 Oct
RX Application: 204767

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2015-10-28

204767 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

204767

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2015-10-28

Regulatory Status

RX

2012
07 Nov
RX Application: 200644

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2012-11-07

200644 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

200644

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2012-11-07

Regulatory Status

RX

1998
13 May
RX Application: 74930

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1998-05-13

74930 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74930

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1998-05-13

Regulatory Status

RX

2024
25 Jun
RX Application: 215404

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2024-06-25

215404 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

215404

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2024-06-25

Regulatory Status

RX

2005
27 Apr
RX Application: 77133

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2005-04-27

77133 / 1

Active Ingredient

ADENOSINE

Application Number

77133

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2005-04-27

Regulatory Status

RX

2017
27 Nov
RX Application: 77897

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

60MG/20ML (3MG/ML)

Approval Date

2017-11-27

77897 / 1

Active Ingredient

ADENOSINE

Application Number

77897

Product Number

1

Dosage Form

-

Strength

60MG/20ML (3MG/ML)

Approval Date

2017-11-27

Regulatory Status

RX

2017
27 Nov
RX Application: 77897

Drug Name

ADENOSINE

Product Number

2

Dosage Form

-

Strength

90MG/30ML (3MG/ML)

Approval Date

2017-11-27

77897 / 2

Active Ingredient

ADENOSINE

Application Number

77897

Product Number

2

Dosage Form

-

Strength

90MG/30ML (3MG/ML)

Approval Date

2017-11-27

Regulatory Status

RX

2018
16 Apr
RX Application: 205568

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2018-04-16

205568 / 1

Active Ingredient

ADENOSINE

Application Number

205568

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2018-04-16

Regulatory Status

RX

2015
09 Dec
RX Application: 205604

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

2015-12-09

205604 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

205604

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

2015-12-09

Regulatory Status

RX

2002
15 Oct
RX Application: 75761

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2002-10-15

75761 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75761

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2002-10-15

Regulatory Status

RX

2018
31 Aug
RX Application: 208231

Drug Name

ARSENIC TRIOXIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2018-08-31

208231 / 1

Active Ingredient

ARSENIC TRIOXIDE

Application Number

208231

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2018-08-31

Regulatory Status

RX

2025
07 Aug
RX Application: 217131

Drug Name

ASCORBIC ACID

Product Number

1

Dosage Form

-

Strength

25,000MG/50ML (500MG/ML)

Approval Date

2025-08-07

217131 / 1

Active Ingredient

ASCORBIC ACID

Application Number

217131

Product Number

1

Dosage Form

-

Strength

25,000MG/50ML (500MG/ML)

Approval Date

2025-08-07

Regulatory Status

RX

2018
26 Jan
RX Application: 209260

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

8MG/20ML (0.4MG/ML)

Approval Date

2018-01-26

209260 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

209260

Product Number

1

Dosage Form

-

Strength

8MG/20ML (0.4MG/ML)

Approval Date

2018-01-26

Regulatory Status

RX

2005
13 Dec
RX Application: 65179

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-12-13

65179 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65179

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-12-13

Regulatory Status

RX

2010
18 Jun
RX Application: 65439

Drug Name

AZTREONAM

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2010-06-18

65439 / 1

Active Ingredient

AZTREONAM

Application Number

65439

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2010-06-18

Regulatory Status

RX

2010
18 Jun
RX Application: 65439

Drug Name

AZTREONAM

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2010-06-18

65439 / 2

Active Ingredient

AZTREONAM

Application Number

65439

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2010-06-18

Regulatory Status

RX

2010
18 Jun
RX Application: 65439

Drug Name

AZTREONAM

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2010-06-18

65439 / 3

Active Ingredient

AZTREONAM

Application Number

65439

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2010-06-18

Regulatory Status

RX

1985
07 Feb
RX Application: 88911

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1985-02-07

88911 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

88911

Product Number

1

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1985-02-07

Regulatory Status

RX

1985
17 May
RX Application: 88911

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1985-05-17

88911 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

88911

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1985-05-17

Regulatory Status

RX

2009
28 Jul
RX Application: 90233

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-07-28

90233 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

90233

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-07-28

Regulatory Status

RX

2016
28 Oct
RX Application: 90189

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2016-10-28

90189 / 1

Active Ingredient

BIVALIRUDIN

Application Number

90189

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2016-10-28

Regulatory Status

RX

2008
28 Jan
RX Application: 65185

Drug Name

BLEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2008-01-28

65185 / 1

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65185

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2008-01-28

Regulatory Status

RX

2008
28 Jan
RX Application: 65185

Drug Name

BLEOMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2008-01-28

65185 / 2

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65185

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2008-01-28

Regulatory Status

RX

2022
02 May
RX Application: 209659

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

209659 / 1

Active Ingredient

BORTEZOMIB

Application Number

209659

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

2007
20 Jul
RX Application: 77997

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2007-07-20

77997 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

77997

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2007-07-20

Regulatory Status

RX

2008
31 Jan
RX Application: 78002

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2008-01-31

78002 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

78002

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2008-01-31

Regulatory Status

RX

2024
05 Dec
RX Application: 212675

Drug Name

CALCITONIN-SALMON

Product Number

1

Dosage Form

-

Strength

200 IU/ML

Approval Date

2024-12-05

212675 / 1

Active Ingredient

CALCITONIN SALMON

Application Number

212675

Product Number

1

Dosage Form

-

Strength

200 IU/ML

Approval Date

2024-12-05

Regulatory Status

RX

2017
15 Jun
RX Application: 208418

Drug Name

CALCIUM GLUCONATE

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2017-06-15

208418 / 1

Active Ingredient

CALCIUM GLUCONATE

Application Number

208418

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2017-06-15

Regulatory Status

RX

2017
15 Jun
RX Application: 208418

Drug Name

CALCIUM GLUCONATE

Product Number

2

Dosage Form

-

Strength

5GM/50ML (100MG/ML)

Approval Date

2017-06-15

208418 / 2

Active Ingredient

CALCIUM GLUCONATE

Application Number

208418

Product Number

2

Dosage Form

-

Strength

5GM/50ML (100MG/ML)

Approval Date

2017-06-15

Regulatory Status

RX

2017
15 Jun
RX Application: 208418

Drug Name

CALCIUM GLUCONATE

Product Number

3

Dosage Form

-

Strength

10GM/100ML (100MG/ML)

Approval Date

2017-06-15

208418 / 3

Active Ingredient

CALCIUM GLUCONATE

Application Number

208418

Product Number

3

Dosage Form

-

Strength

10GM/100ML (100MG/ML)

Approval Date

2017-06-15

Regulatory Status

RX

2006
15 Feb
RX Application: 77266

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2006-02-15

77266 / 3

Active Ingredient

CARBOPLATIN

Application Number

77266

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2006-02-15

Regulatory Status

RX

2006
15 Feb
RX Application: 77266

Drug Name

CARBOPLATIN

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2006-02-15

77266 / 4

Active Ingredient

CARBOPLATIN

Application Number

77266

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2006-02-15

Regulatory Status

RX

2022
18 Feb
RX Application: 214623

Drug Name

CARDIOPLEGIC IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

Approval Date

2022-02-18

214623 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

214623

Product Number

1

Dosage Form

-

Strength

17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

Approval Date

2022-02-18

Regulatory Status

RX

2016
30 Dec
RX Application: 206110

Drug Name

CASPOFUNGIN ACETATE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2016-12-30

206110 / 1

Active Ingredient

CASPOFUNGIN ACETATE

Application Number

206110

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2016-12-30

Regulatory Status

RX

2016
30 Dec
RX Application: 206110

Drug Name

CASPOFUNGIN ACETATE

Product Number

2

Dosage Form

-

Strength

70MG/VIAL

Approval Date

2016-12-30

206110 / 2

Active Ingredient

CASPOFUNGIN ACETATE

Application Number

206110

Product Number

2

Dosage Form

-

Strength

70MG/VIAL

Approval Date

2016-12-30

Regulatory Status

RX

2007
09 Aug
RX Application: 65374

Drug Name

CEFOTETAN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-08-09

65374 / 1

Active Ingredient

CEFOTETAN DISODIUM

Application Number

65374

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-08-09

Regulatory Status

RX

2007
09 Aug
RX Application: 65374

Drug Name

CEFOTETAN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-08-09

65374 / 2

Active Ingredient

CEFOTETAN DISODIUM

Application Number

65374

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-08-09

Regulatory Status

RX

2009
16 Oct
RX Application: 90896

Drug Name

CHLOROTHIAZIDE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-10-16

90896 / 1

Active Ingredient

CHLOROTHIAZIDE SODIUM

Application Number

90896

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-10-16

Regulatory Status

RX

2015
26 Feb
RX Application: 203183

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2015-02-26

203183 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203183

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2015-02-26

Regulatory Status

RX

2015
26 Feb
RX Application: 203182

Drug Name

CISATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2015-02-26

203182 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203182

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2015-02-26

Regulatory Status

RX

2015
26 Feb
RX Application: 203182

Drug Name

CISATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2015-02-26

203182 / 2

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203182

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2015-02-26

Regulatory Status

RX

1999
16 Jul
RX Application: 74735

Drug Name

CISPLATIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1999-07-16

74735 / 1

Active Ingredient

CISPLATIN

Application Number

74735

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1999-07-16

Regulatory Status

RX

2004
22 Apr
RX Application: 76571

Drug Name

CLADRIBINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-04-22

76571 / 1

Active Ingredient

CLADRIBINE

Application Number

76571

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-04-22

Regulatory Status

RX

2011
08 Jul
RX Application: 200673

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2011-07-08

200673 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

200673

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2011-07-08

Regulatory Status

RX

2011
08 Jul
RX Application: 200673

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2011-07-08

200673 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

200673

Product Number

2

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2011-07-08

Regulatory Status

RX

2008
17 Apr
RX Application: 65364

Drug Name

COLISTIMETHATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2008-04-17

65364 / 1

Active Ingredient

COLISTIMETHATE SODIUM

Application Number

65364

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2008-04-17

Regulatory Status

RX

2004
15 Jan
RX Application: 76512

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2004-01-15

76512 / 1

Active Ingredient

CYTARABINE

Application Number

76512

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2004-01-15

Regulatory Status

RX

1999
27 Aug
RX Application: 75371

Drug Name

DACARBAZINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1999-08-27

75371 / 1

Active Ingredient

DACARBAZINE

Application Number

75371

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1999-08-27

Regulatory Status

RX

1999
27 Aug
RX Application: 75371

Drug Name

DACARBAZINE

Product Number

2

Dosage Form

-

Strength

200MG/VIAL

Approval Date

1999-08-27

75371 / 2

Active Ingredient

DACARBAZINE

Application Number

75371

Product Number

2

Dosage Form

-

Strength

200MG/VIAL

Approval Date

1999-08-27

Regulatory Status

RX

2025
10 Nov
RX Application: 217591

Drug Name

DALBAVANCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2025-11-10

217591 / 1

Active Ingredient

DALBAVANCIN HYDROCHLORIDE

Application Number

217591

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2025-11-10

Regulatory Status

RX

2018
11 Apr
RX Application: 206077

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2018-04-11

206077 / 1

Active Ingredient

DAPTOMYCIN

Application Number

206077

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2018-04-11

Regulatory Status

RX

1999
25 May
RX Application: 65000

Drug Name

DAUNORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1999-05-25

65000 / 1

Active Ingredient

DAUNORUBICIN HYDROCHLORIDE

Application Number

65000

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1999-05-25

Regulatory Status

RX

2009
15 Sep
RX Application: 78718

Drug Name

DEFEROXAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2009-09-15

78718 / 1

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

78718

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2009-09-15

Regulatory Status

RX

2009
15 Sep
RX Application: 78718

Drug Name

DEFEROXAMINE MESYLATE

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2009-09-15

78718 / 2

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

78718

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2009-09-15

Regulatory Status

RX

2005
22 Apr
RX Application: 40572

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2005-04-22

40572 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

40572

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2005-04-22

Regulatory Status

RX

1982
01 Jan
RX Application: 84916

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

1982-01-01

84916 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

84916

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

1982-01-01

Regulatory Status

RX

2015
30 Sep
RX Application: 203129

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2015-09-30

203129 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

203129

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2015-09-30

Regulatory Status

RX

2018
06 Jul
RX Application: 209192

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2018-07-06

209192 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

209192

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2018-07-06

Regulatory Status

RX

2003
11 Apr
RX Application: 40491

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2003-04-11

40491 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

40491

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2003-04-11

Regulatory Status

RX

2015
18 Sep
RX Application: 201072

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2015-09-18

201072 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

201072

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2015-09-18

Regulatory Status

RX

2018
29 Nov
RX Application: 208129

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

Approval Date

2018-11-29

208129 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

208129

Product Number

1

Dosage Form

-

Strength

EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

Approval Date

2018-11-29

Regulatory Status

RX

2018
29 Nov
RX Application: 208129

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date

2018-11-29

208129 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

208129

Product Number

2

Dosage Form

-

Strength

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date

2018-11-29

Regulatory Status

RX

2018
29 Nov
RX Application: 208129

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date

2018-11-29

208129 / 3

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

208129

Product Number

3

Dosage Form

-

Strength

EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date

2018-11-29

Regulatory Status

RX

2018
16 Jul
RX Application: 209448

Drug Name

DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

10GM/100ML

Approval Date

2018-07-16

209448 / 1

Active Ingredient

DEXTROSE

Application Number

209448

Product Number

1

Dosage Form

-

Strength

10GM/100ML

Approval Date

2018-07-16

Regulatory Status

RX

2019
20 Dec
RX Application: 211190

Drug Name

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.5GM/100ML;450MG/100ML

Approval Date

2019-12-20

211190 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

211190

Product Number

1

Dosage Form

-

Strength

2.5GM/100ML;450MG/100ML

Approval Date

2019-12-20

Regulatory Status

RX

2022
28 Mar
RX Application: 210332

Drug Name

DEXTROSE 5% AND LACTATED RINGERS

Product Number

1

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Approval Date

2022-03-28

210332 / 1

Active Ingredient

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

210332

Product Number

1

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Approval Date

2022-03-28

Regulatory Status

RX

2020
10 Sep
RX Application: 212346

Drug Name

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%

Product Number

1

Dosage Form

-

Strength

5GM/100ML;75MG/100ML

Approval Date

2020-09-10

212346 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE

Application Number

212346

Product Number

1

Dosage Form

-

Strength

5GM/100ML;75MG/100ML

Approval Date

2020-09-10

Regulatory Status

RX

2020
10 Sep
RX Application: 212346

Drug Name

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%

Product Number

2

Dosage Form

-

Strength

5GM/100ML;150MG/100ML

Approval Date

2020-09-10

212346 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE

Application Number

212346

Product Number

2

Dosage Form

-

Strength

5GM/100ML;150MG/100ML

Approval Date

2020-09-10

Regulatory Status

RX

2020
15 Sep
RX Application: 211221

Drug Name

DEXTROSE 5% AND SODIUM CHLORIDE 0.225%

Product Number

1

Dosage Form

-

Strength

5GM/100ML;225MG/100ML

Approval Date

2020-09-15

211221 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

211221

Product Number

1

Dosage Form

-

Strength

5GM/100ML;225MG/100ML

Approval Date

2020-09-15

Regulatory Status

RX

2020
26 Aug
RX Application: 211194

Drug Name

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;300MG/100ML

Approval Date

2020-08-26

211194 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

211194

Product Number

1

Dosage Form

-

Strength

5GM/100ML;300MG/100ML

Approval Date

2020-08-26

Regulatory Status

RX

2020
15 Sep
RX Application: 211276

Drug Name

DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Product Number

1

Dosage Form

-

Strength

5GM/100ML;450MG/100ML

Approval Date

2020-09-15

211276 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

211276

Product Number

1

Dosage Form

-

Strength

5GM/100ML;450MG/100ML

Approval Date

2020-09-15

Regulatory Status

RX

2020
14 Sep
RX Application: 211211

Drug Name

DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

5GM/100ML;900MG/100ML

Approval Date

2020-09-14

211211 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

211211

Product Number

1

Dosage Form

-

Strength

5GM/100ML;900MG/100ML

Approval Date

2020-09-14

Regulatory Status

RX

2016
21 Oct
RX Application: 207449

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2016-10-21

207449 / 1

Active Ingredient

DEXTROSE

Application Number

207449

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2016-10-21

Regulatory Status

RX

2022
10 Nov
RX Application: 214745

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2022-11-10

214745 / 1

Active Ingredient

DIAZEPAM

Application Number

214745

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2022-11-10

Regulatory Status

RX

2019
25 Jan
RX Application: 210257

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-01-25

210257 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

210257

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-01-25

Regulatory Status

RX

2009
30 Apr
RX Application: 19034

Drug Name

DILAUDID

Product Number

3

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-04-30

19034 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19034

Product Number

3

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-04-30

Regulatory Status

RX

2009
30 Apr
RX Application: 19034

Drug Name

DILAUDID

Product Number

4

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-04-30

19034 / 4

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19034

Product Number

4

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-04-30

Regulatory Status

RX

2009
30 Apr
RX Application: 19034

Drug Name

DILAUDID

Product Number

5

Dosage Form

-

Strength

4MG/ML

Approval Date

2009-04-30

19034 / 5

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19034

Product Number

5

Dosage Form

-

Strength

4MG/ML

Approval Date

2009-04-30

Regulatory Status

RX

2020
16 Jan
RX Application: 19034

Drug Name

DILAUDID

Product Number

6

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2020-01-16

19034 / 6

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19034

Product Number

6

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2020-01-16

Regulatory Status

RX

2017
10 Feb
RX Application: 19034

Drug Name

DILAUDID

Product Number

7

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2017-02-10

19034 / 7

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19034

Product Number

7

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2017-02-10

Regulatory Status

RX

1984
11 Jan
RX Application: 19034

Drug Name

DILAUDID-HP

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1984-01-11

19034 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19034

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1984-01-11

Regulatory Status

RX

2004
23 Jun
RX Application: 40519

Drug Name

DIMENHYDRINATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2004-06-23

40519 / 1

Active Ingredient

DIMENHYDRINATE

Application Number

40519

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2004-06-23

Regulatory Status

RX

2013
26 Mar
RX Application: 91526

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2013-03-26

91526 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

91526

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2013-03-26

Regulatory Status

RX

1996
11 Jun
RX Application: 19627

Drug Name

DIPRIVAN

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1996-06-11

19627 / 2

Active Ingredient

PROPOFOL

Application Number

19627

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1996-06-11

Regulatory Status

RX

1995
26 Oct
RX Application: 63277

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1995-10-26

63277 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

63277

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1995-10-26

Regulatory Status

RX

1983
09 Dec
RX Application: 62475

Drug Name

DOXY 100

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1983-12-09

62475 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62475

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1983-12-09

Regulatory Status

RX

1983
09 Dec
RX Application: 62475

Drug Name

DOXY 200

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1983-12-09

62475 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62475

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1983-12-09

Regulatory Status

RX

2020
04 Aug
RX Application: 209646

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2020-08-04

209646 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

209646

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2020-08-04

Regulatory Status

RX

2025
11 Mar
RX Application: 218271

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

25MG/5ML (5MG/ML)

Approval Date

2025-03-11

218271 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

218271

Product Number

1

Dosage Form

-

Strength

25MG/5ML (5MG/ML)

Approval Date

2025-03-11

Regulatory Status

RX

2025
11 Mar
RX Application: 218271

Drug Name

EPHEDRINE SULFATE

Product Number

2

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2025-03-11

218271 / 2

Active Ingredient

EPHEDRINE SULFATE

Application Number

218271

Product Number

2

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2025-03-11

Regulatory Status

RX

2026
19 Mar
RX Application: 219991

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2026-03-19

219991 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

219991

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2026-03-19

Regulatory Status

RX

2024
20 Nov
RX Application: 213708

Drug Name

EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2024-11-20

213708 / 1

Active Ingredient

EPINEPHRINE

Application Number

213708

Product Number

1

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2024-11-20

Regulatory Status

RX

2025
13 Mar
RX Application: 215425

Drug Name

EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

30MG/30ML (1MG/ML)

Approval Date

2025-03-13

215425 / 1

Active Ingredient

EPINEPHRINE

Application Number

215425

Product Number

1

Dosage Form

-

Strength

30MG/30ML (1MG/ML)

Approval Date

2025-03-13

Regulatory Status

RX

1998
30 Sep
RX Application: 74983

Drug Name

ETOPOSIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1998-09-30

74983 / 1

Active Ingredient

ETOPOSIDE

Application Number

74983

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1998-09-30

Regulatory Status

RX

2001
16 Apr
RX Application: 75709

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

75709 / 1

Active Ingredient

FAMOTIDINE

Application Number

75709

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

Regulatory Status

RX

2001
16 Apr
RX Application: 75813

Drug Name

FAMOTIDINE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

75813 / 1

Active Ingredient

FAMOTIDINE

Application Number

75813

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

Regulatory Status

RX

2020
01 Sep
RX Application: 212086

Drug Name

FENTANYL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2020-09-01

212086 / 1

Active Ingredient

FENTANYL CITRATE

Application Number

212086

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2020-09-01

Regulatory Status

RX

2019
03 May
RX Application: 210762

Drug Name

FENTANYL CITRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2019-05-03

210762 / 1

Active Ingredient

FENTANYL CITRATE

Application Number

210762

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2019-05-03

Regulatory Status

RX

2001
22 Feb
RX Application: 75837

Drug Name

FLOXURIDINE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2001-02-22

75837 / 1

Active Ingredient

FLOXURIDINE

Application Number

75837

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2001-02-22

Regulatory Status

RX

2004
29 Jul
RX Application: 76145

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

76145 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76145

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2004
29 Jul
RX Application: 76145

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

76145 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76145

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2007
15 Oct
RX Application: 78393

Drug Name

FLUDARABINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

50MG/2ML (25MG/ML)

Approval Date

2007-10-15

78393 / 1

Active Ingredient

FLUDARABINE PHOSPHATE

Application Number

78393

Product Number

1

Dosage Form

-

Strength

50MG/2ML (25MG/ML)

Approval Date

2007-10-15

Regulatory Status

RX

2007
15 Oct
RX Application: 78544

Drug Name

FLUDARABINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2007-10-15

78544 / 1

Active Ingredient

FLUDARABINE PHOSPHATE

Application Number

78544

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2007-10-15

Regulatory Status

RX

2004
12 Oct
RX Application: 76955

Drug Name

FLUMAZENIL

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

76955 / 1

Active Ingredient

FLUMAZENIL

Application Number

76955

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

RX

2004
12 Oct
RX Application: 76955

Drug Name

FLUMAZENIL

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

76955 / 2

Active Ingredient

FLUMAZENIL

Application Number

76955

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

RX

1998
30 Sep
RX Application: 40278

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML)

Approval Date

1998-09-30

40278 / 1

Active Ingredient

FLUOROURACIL

Application Number

40278

Product Number

1

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML)

Approval Date

1998-09-30

Regulatory Status

RX

1998
30 Sep
RX Application: 40278

Drug Name

FLUOROURACIL

Product Number

2

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

1998-09-30

40278 / 2

Active Ingredient

FLUOROURACIL

Application Number

40278

Product Number

2

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

1998-09-30

Regulatory Status

RX

1998
30 Sep
RX Application: 40279

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

1GM/20ML (50MG/ML)

Approval Date

1998-09-30

40279 / 1

Active Ingredient

FLUOROURACIL

Application Number

40279

Product Number

1

Dosage Form

-

Strength

1GM/20ML (50MG/ML)

Approval Date

1998-09-30

Regulatory Status

RX

1998
30 Sep
RX Application: 40279

Drug Name

FLUOROURACIL

Product Number

2

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

1998-09-30

40279 / 2

Active Ingredient

FLUOROURACIL

Application Number

40279

Product Number

2

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

1998-09-30

Regulatory Status

RX

1987
14 Jul
RX Application: 71413

Drug Name

FLUPHENAZINE DECANOATE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1987-07-14

71413 / 1

Active Ingredient

FLUPHENAZINE DECANOATE

Application Number

71413

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1987-07-14

Regulatory Status

RX

1987
16 Apr
RX Application: 89556

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-04-16

89556 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

89556

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-04-16

Regulatory Status

RX

1986
18 Feb
RX Application: 89202

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1986-02-18

89202 / 1

Active Ingredient

FOLIC ACID

Application Number

89202

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1986-02-18

Regulatory Status

RX

2016
09 Jun
RX Application: 206197

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2016-06-09

206197 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

206197

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2016-06-09

Regulatory Status

RX

2021
29 Jan
RX Application: 212483

Drug Name

FOSCARNET SODIUM

Product Number

1

Dosage Form

-

Strength

6GM/250ML (24MG/ML)

Approval Date

2021-01-29

212483 / 1

Active Ingredient

FOSCARNET SODIUM

Application Number

212483

Product Number

1

Dosage Form

-

Strength

6GM/250ML (24MG/ML)

Approval Date

2021-01-29

Regulatory Status

RX

2007
06 Aug
RX Application: 78052

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

78052 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

78052

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

Regulatory Status

RX

2019
20 May
RX Application: 210326

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-05-20

210326 / 1

Active Ingredient

FULVESTRANT

Application Number

210326

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-05-20

Regulatory Status

RX

1984
22 May
RX Application: 18902

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1984-05-22

18902 / 1

Active Ingredient

FUROSEMIDE

Application Number

18902

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1984-05-22

Regulatory Status

RX

2010
21 Jun
RX Application: 90658

Drug Name

GANCICLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2010-06-21

90658 / 1

Active Ingredient

GANCICLOVIR SODIUM

Application Number

90658

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2010-06-21

Regulatory Status

RX

2011
16 May
RX Application: 90242

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2011-05-16

90242 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

90242

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2011-05-16

Regulatory Status

RX

2011
25 Jul
RX Application: 90799

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

90799 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

90799

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2011
25 Jul
RX Application: 90799

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

90799 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

90799

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2011
16 May
RX Application: 90799

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2011-05-16

90799 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

90799

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2011-05-16

Regulatory Status

RX

1983
04 Aug
RX Application: 62366

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1983-08-04

62366 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62366

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1983-08-04

Regulatory Status

RX

1986
06 Feb
RX Application: 62366

Drug Name

GENTAMICIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1986-02-06

62366 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62366

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1986-02-06

Regulatory Status

RX

2015
08 May
RX Application: 201849

Drug Name

GLUCAGON

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2015-05-08

201849 / 1

Active Ingredient

GLUCAGON HYDROCHLORIDE

Application Number

201849

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2015-05-08

Regulatory Status

RX

2019
19 Sep
RX Application: 201849

Drug Name

GLUCAGON

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2019-09-19

201849 / 2

Active Ingredient

GLUCAGON HYDROCHLORIDE

Application Number

201849

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2019-09-19

Regulatory Status

RX

2026
29 Jul
RX Application: 220381

Drug Name

GLYCOPHOS

Product Number

1

Dosage Form

-

Strength

4.32GM/20ML (216MG/ML)

Approval Date

2026-07-29

220381 / 1

Active Ingredient

SODIUM GLYCEROPHOSPHATE

Application Number

220381

Product Number

1

Dosage Form

-

Strength

4.32GM/20ML (216MG/ML)

Approval Date

2026-07-29

Regulatory Status

RX

2026
29 Jul
RX Application: 220381

Drug Name

GLYCOPHOS

Product Number

2

Dosage Form

-

Strength

21.6GM/100ML (216MG/ML)

Approval Date

2026-07-29

220381 / 2

Active Ingredient

SODIUM GLYCEROPHOSPHATE

Application Number

220381

Product Number

2

Dosage Form

-

Strength

21.6GM/100ML (216MG/ML)

Approval Date

2026-07-29

Regulatory Status

RX

2018
31 Oct
RX Application: 209024

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2018-10-31

209024 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

209024

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2018-10-31

Regulatory Status

RX

2017
27 Oct
RX Application: 209328

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2017-10-27

209328 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

209328

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2017-10-27

Regulatory Status

RX

2022
21 Apr
RX Application: 214919

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.6MG/3ML (0.2MG/ML)

Approval Date

2022-04-21

214919 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

214919

Product Number

1

Dosage Form

-

Strength

0.6MG/3ML (0.2MG/ML)

Approval Date

2022-04-21

Regulatory Status

RX

2008
30 Jun
RX Application: 78090

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

78090 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78090

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2007
31 Dec
RX Application: 78522

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2007-12-31

78522 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78522

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2007-12-31

Regulatory Status

RX

2008
30 Jun
RX Application: 78096

Drug Name

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

78096 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78096

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2001
09 Mar
RX Application: 75689

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2001-03-09

75689 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

75689

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2001-03-09

Regulatory Status

RX

1997
19 Dec
RX Application: 74893

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1997-12-19

74893 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

74893

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1997-12-19

Regulatory Status

RX

1997
19 Dec
RX Application: 74893

Drug Name

HALOPERIDOL DECANOATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1997-12-19

74893 / 2

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

74893

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1997-12-19

Regulatory Status

RX

1982
01 Jan
RX Application: 17029

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

17029 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17029

Drug Name

HEPARIN SODIUM

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

17029 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17029

Drug Name

HEPARIN SODIUM

Product Number

4

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1982-01-01

17029 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

4

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

2011
31 Mar
RX Application: 17029

Drug Name

HEPARIN SODIUM

Product Number

20

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2011-03-31

17029 / 20

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

20

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2011-03-31

Regulatory Status

RX

1982
01 Jan
RX Application: 17651

Drug Name

HEPARIN SODIUM

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1982-01-01

17651 / 6

Active Ingredient

HEPARIN SODIUM

Application Number

17651

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

2016
10 Jun
RX Application: 206552

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

2016-06-10

206552 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

206552

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

2016-06-10

Regulatory Status

RX

2020
24 Jul
RX Application: 212441

Drug Name

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

2020-07-24

212441 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

212441

Product Number

1

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

2020-07-24

Regulatory Status

RX

2020
24 Jul
RX Application: 212441

Drug Name

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

2020-07-24

212441 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

212441

Product Number

2

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

2020-07-24

Regulatory Status

RX

2017
24 Aug
RX Application: 17029

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%

Product Number

22

Dosage Form

-

Strength

50 UNITS/ML

Approval Date

2017-08-24

17029 / 22

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

22

Dosage Form

-

Strength

50 UNITS/ML

Approval Date

2017-08-24

Regulatory Status

RX

2017
24 Aug
RX Application: 17029

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%

Product Number

23

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

2017-08-24

17029 / 23

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

23

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

2017-08-24

Regulatory Status

RX

2017
24 Aug
RX Application: 17029

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%

Product Number

24

Dosage Form

-

Strength

50 UNITS/ML

Approval Date

2017-08-24

17029 / 24

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

24

Dosage Form

-

Strength

50 UNITS/ML

Approval Date

2017-08-24

Regulatory Status

RX

2017
24 Aug
RX Application: 17029

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%

Product Number

25

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

2017-08-24

17029 / 25

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

25

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

2017-08-24

Regulatory Status

RX

1985
05 Dec
RX Application: 17029

Drug Name

HEPARIN SODIUM IN PLASTIC CONTAINER

Product Number

13

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1985-12-05

17029 / 13

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

13

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1985-12-05

Regulatory Status

RX

1985
05 Dec
RX Application: 17029

Drug Name

HEPARIN SODIUM IN PLASTIC CONTAINER

Product Number

14

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1985-12-05

17029 / 14

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

14

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1985-12-05

Regulatory Status

RX

1985
05 Dec
RX Application: 17029

Drug Name

HEPARIN SODIUM IN PLASTIC CONTAINER

Product Number

15

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1985-12-05

17029 / 15

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

15

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1985-12-05

Regulatory Status

RX

1985
05 Dec
RX Application: 17029

Drug Name

HEPARIN SODIUM IN PLASTIC CONTAINER

Product Number

16

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1985-12-05

17029 / 16

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

16

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1985-12-05

Regulatory Status

RX

1986
28 Apr
RX Application: 17029

Drug Name

HEPARIN SODIUM PRESERVATIVE FREE

Product Number

10

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1986-04-28

17029 / 10

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

10

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1986-04-28

Regulatory Status

RX

2010
22 Nov
RX Application: 17029

Drug Name

HEPARIN SODIUM PRESERVATIVE FREE

Product Number

19

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2010-11-22

17029 / 19

Active Ingredient

HEPARIN SODIUM

Application Number

17029

Product Number

19

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2010-11-22

Regulatory Status

RX

2001
13 Mar
RX Application: 40388

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2001-03-13

40388 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

40388

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2001-03-13

Regulatory Status

RX

2020
18 Jun
RX Application: 208317

Drug Name

ICATIBANT ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2020-06-18

208317 / 1

Active Ingredient

ICATIBANT ACETATE

Application Number

208317

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2020-06-18

Regulatory Status

RX

2002
28 May
RX Application: 76078

Drug Name

IFOSFAMIDE

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2002-05-28

76078 / 1

Active Ingredient

IFOSFAMIDE

Application Number

76078

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2002-05-28

Regulatory Status

RX

2002
28 May
RX Application: 76078

Drug Name

IFOSFAMIDE

Product Number

2

Dosage Form

-

Strength

3GM/VIAL

Approval Date

2002-05-28

76078 / 2

Active Ingredient

IFOSFAMIDE

Application Number

76078

Product Number

2

Dosage Form

-

Strength

3GM/VIAL

Approval Date

2002-05-28

Regulatory Status

RX

2010
17 Mar
RX Application: 22536

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2010-03-17

22536 / 1

Active Ingredient

INDOMETHACIN

Application Number

22536

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2010-03-17

Regulatory Status

RX

2008
27 Feb
RX Application: 77776

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

77776 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77776

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

2008
27 Feb
RX Application: 77776

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

77776 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77776

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

KABIVEN IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

Approval Date

2014-08-25

200656 / 4

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

4

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

KABIVEN IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

Approval Date

2014-08-25

200656 / 5

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

5

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

KABIVEN IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

Approval Date

2014-08-25

200656 / 6

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

6

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

KABIVEN IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

Approval Date

2014-08-25

200656 / 7

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

7

Dosage Form

-

Strength

3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

Approval Date

2014-08-25

Regulatory Status

RX

2023
13 Jan
RX Application: 215808

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2023-01-13

215808 / 1

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

215808

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2023-01-13

Regulatory Status

RX

2023
13 Jan
RX Application: 215808

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2023-01-13

215808 / 2

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

215808

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2023-01-13

Regulatory Status

RX

2025
18 Apr
RX Application: 215808

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2025-04-18

215808 / 3

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

215808

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2025-04-18

Regulatory Status

RX

2002
11 Jan
RX Application: 75784

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2002-01-11

75784 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75784

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2002-01-11

Regulatory Status

RX

2002
11 Jan
RX Application: 75784

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2002-01-11

75784 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75784

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2002-01-11

Regulatory Status

RX

2015
07 Oct
RX Application: 203242

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2015-10-07

203242 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

203242

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2015-10-07

Regulatory Status

RX

2022
03 May
RX Application: 214677

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2022-05-03

214677 / 1

Active Ingredient

LACOSAMIDE

Application Number

214677

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2022-05-03

Regulatory Status

RX

2019
28 Jan
RX Application: 209338

Drug Name

LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Approval Date

2019-01-28

209338 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

209338

Product Number

1

Dosage Form

-

Strength

20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Approval Date

2019-01-28

Regulatory Status

RX

2018
27 Jul
RX Application: 207226

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/50ML (EQ 10MG BASE/ML)

Approval Date

2018-07-27

207226 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

207226

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/50ML (EQ 10MG BASE/ML)

Approval Date

2018-07-27

Regulatory Status

RX

2018
14 Mar
RX Application: 207241

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/10ML (EQ 10MG BASE/ML)

Approval Date

2018-03-14

207241 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

207241

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/10ML (EQ 10MG BASE/ML)

Approval Date

2018-03-14

Regulatory Status

RX

1999
26 Feb
RX Application: 40258

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1999-02-26

40258 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40258

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1999-02-26

Regulatory Status

RX

1999
26 Feb
RX Application: 40286

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1999-02-26

40286 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40286

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1999-02-26

Regulatory Status

RX

2015
13 Aug
RX Application: 90876

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2015-08-13

90876 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90876

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2015-08-13

Regulatory Status

RX

2023
31 Jan
RX Application: 208619

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2023-01-31

208619 / 1

Active Ingredient

LEVETIRACETAM

Application Number

208619

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2023-01-31

Regulatory Status

RX

2023
31 Jan
RX Application: 208619

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-01-31

208619 / 2

Active Ingredient

LEVETIRACETAM

Application Number

208619

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-01-31

Regulatory Status

RX

2023
31 Jan
RX Application: 208619

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2023-01-31

208619 / 3

Active Ingredient

LEVETIRACETAM

Application Number

208619

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2023-01-31

Regulatory Status

RX

2013
19 Jun
RX Application: 200674

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Approval Date

2013-06-19

200674 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

200674

Product Number

1

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Approval Date

2013-06-19

Regulatory Status

RX

2013
19 Jun
RX Application: 200674

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML)

Approval Date

2013-06-19

200674 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

200674

Product Number

2

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML)

Approval Date

2013-06-19

Regulatory Status

RX

2013
19 Jun
RX Application: 200674

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML)

Approval Date

2013-06-19

200674 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

200674

Product Number

3

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML)

Approval Date

2013-06-19

Regulatory Status

RX

2011
24 Jun
RX Application: 202231

Drug Name

LEVOTHYROXINE SODIUM

Product Number

1

Dosage Form

-

Strength

100MCG/VIAL

Approval Date

2011-06-24

202231 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

202231

Product Number

1

Dosage Form

-

Strength

100MCG/VIAL

Approval Date

2011-06-24

Regulatory Status

RX

2011
24 Jun
RX Application: 202231

Drug Name

LEVOTHYROXINE SODIUM

Product Number

2

Dosage Form

-

Strength

200MCG/VIAL

Approval Date

2011-06-24

202231 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

202231

Product Number

2

Dosage Form

-

Strength

200MCG/VIAL

Approval Date

2011-06-24

Regulatory Status

RX

2011
24 Jun
RX Application: 202231

Drug Name

LEVOTHYROXINE SODIUM

Product Number

3

Dosage Form

-

Strength

500MCG/VIAL

Approval Date

2011-06-24

202231 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

202231

Product Number

3

Dosage Form

-

Strength

500MCG/VIAL

Approval Date

2011-06-24

Regulatory Status

RX

2019
11 Apr
RX Application: 210632

Drug Name

LEVOTHYROXINE SODIUM

Product Number

1

Dosage Form

-

Strength

100MCG/5ML (20MCG/ML)

Approval Date

2019-04-11

210632 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

210632

Product Number

1

Dosage Form

-

Strength

100MCG/5ML (20MCG/ML)

Approval Date

2019-04-11

Regulatory Status

RX

2019
11 Apr
RX Application: 210632

Drug Name

LEVOTHYROXINE SODIUM

Product Number

2

Dosage Form

-

Strength

200MCG/5ML (40MCG/ML)

Approval Date

2019-04-11

210632 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

210632

Product Number

2

Dosage Form

-

Strength

200MCG/5ML (40MCG/ML)

Approval Date

2019-04-11

Regulatory Status

RX

2019
11 Apr
RX Application: 210632

Drug Name

LEVOTHYROXINE SODIUM

Product Number

3

Dosage Form

-

Strength

500MCG/5ML (100MCG/ML)

Approval Date

2019-04-11

210632 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

210632

Product Number

3

Dosage Form

-

Strength

500MCG/5ML (100MCG/ML)

Approval Date

2019-04-11

Regulatory Status

RX

1982
01 Jan
RX Application: 88586

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

88586 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88586

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 88586

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

88586 / 3

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88586

Product Number

3

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

RX

1985
24 Jul
RX Application: 88586

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1985-07-24

88586 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88586

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1985-07-24

Regulatory Status

RX

1982
01 Jan
RX Application: 17584

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

17584 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

17584

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17584

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

4%

Approval Date

1982-01-01

17584 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

17584

Product Number

2

Dosage Form

-

Strength

4%

Approval Date

1982-01-01

Regulatory Status

RX

2016
15 Mar
RX Application: 204764

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2016-03-15

204764 / 1

Active Ingredient

LINEZOLID

Application Number

204764

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2016-03-15

Regulatory Status

RX

2026
30 Mar
RX Application: 212552

Drug Name

LIRAGLUTIDE

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2026-03-30

212552 / 1

Active Ingredient

LIRAGLUTIDE

Application Number

212552

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2026-03-30

Regulatory Status

RX

2024
18 Nov
RX Application: 217598

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2024-11-18

217598 / 1

Active Ingredient

LORAZEPAM

Application Number

217598

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2024-11-18

Regulatory Status

RX

1986
08 Sep
RX Application: 19316

Drug Name

MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

5GM/10ML (500MG/ML)

Approval Date

1986-09-08

19316 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

19316

Product Number

1

Dosage Form

-

Strength

5GM/10ML (500MG/ML)

Approval Date

1986-09-08

Regulatory Status

RX

1986
08 Sep
RX Application: 19316

Drug Name

MAGNESIUM SULFATE

Product Number

2

Dosage Form

-

Strength

1GM/2ML (500MG/ML)

Approval Date

1986-09-08

19316 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

19316

Product Number

2

Dosage Form

-

Strength

1GM/2ML (500MG/ML)

Approval Date

1986-09-08

Regulatory Status

RX

2016
29 Jan
RX Application: 19316

Drug Name

MAGNESIUM SULFATE

Product Number

3

Dosage Form

-

Strength

10GM/20ML (500MG/ML)

Approval Date

2016-01-29

19316 / 3

Active Ingredient

MAGNESIUM SULFATE

Application Number

19316

Product Number

3

Dosage Form

-

Strength

10GM/20ML (500MG/ML)

Approval Date

2016-01-29

Regulatory Status

RX

2016
29 Jan
RX Application: 19316

Drug Name

MAGNESIUM SULFATE

Product Number

4

Dosage Form

-

Strength

25GM/50ML (500MG/ML)

Approval Date

2016-01-29

19316 / 4

Active Ingredient

MAGNESIUM SULFATE

Application Number

19316

Product Number

4

Dosage Form

-

Strength

25GM/50ML (500MG/ML)

Approval Date

2016-01-29

Regulatory Status

RX

2016
07 Mar
RX Application: 206486

Drug Name

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

2016-03-07

206486 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

206486

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

2016-03-07

Regulatory Status

RX

2016
15 Mar
RX Application: 206485

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

2016-03-15

206485 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

206485

Product Number

1

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

2016-03-15

Regulatory Status

RX

2016
15 Mar
RX Application: 206485

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

2016-03-15

206485 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

206485

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

2016-03-15

Regulatory Status

RX

2016
15 Mar
RX Application: 206485

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2016-03-15

206485 / 3

Active Ingredient

MAGNESIUM SULFATE

Application Number

206485

Product Number

3

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2016-03-15

Regulatory Status

RX

2016
15 Mar
RX Application: 206485

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

20GM/500ML (40MG/ML)

Approval Date

2016-03-15

206485 / 4

Active Ingredient

MAGNESIUM SULFATE

Application Number

206485

Product Number

4

Dosage Form

-

Strength

20GM/500ML (40MG/ML)

Approval Date

2016-03-15

Regulatory Status

RX

2016
15 Mar
RX Application: 206485

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

40GM/1000ML (40MG/ML)

Approval Date

2016-03-15

206485 / 5

Active Ingredient

MAGNESIUM SULFATE

Application Number

206485

Product Number

5

Dosage Form

-

Strength

40GM/1000ML (40MG/ML)

Approval Date

2016-03-15

Regulatory Status

RX

2025
07 Jul
RX Application: 217583

Drug Name

MANGANESE CHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG MANGANESE/ML

Approval Date

2025-07-07

217583 / 1

Active Ingredient

MANGANESE CHLORIDE

Application Number

217583

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG MANGANESE/ML

Approval Date

2025-07-07

Regulatory Status

RX

1982
01 Jan
RX Application: 80677

Drug Name

MANNITOL 25%

Product Number

1

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1982-01-01

80677 / 1

Active Ingredient

MANNITOL

Application Number

80677

Product Number

1

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1982-01-01

Regulatory Status

RX

2017
22 Dec
RX Application: 203393

Drug Name

MELPHALAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2017-12-22

203393 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

203393

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2017-12-22

Regulatory Status

RX

2001
26 Apr
RX Application: 75811

Drug Name

MESNA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2001-04-26

75811 / 1

Active Ingredient

MESNA

Application Number

75811

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2001-04-26

Regulatory Status

RX

2018
17 Apr
RX Application: 209331

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2018-04-17

209331 / 1

Active Ingredient

METHOCARBAMOL

Application Number

209331

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2018-04-17

Regulatory Status

RX

1999
26 Feb
RX Application: 40266

Drug Name

METHOTREXATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1999-02-26

40266 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

40266

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1999-02-26

Regulatory Status

RX

1999
26 Feb
RX Application: 40263

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Approval Date

1999-02-26

40263 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

40263

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Approval Date

1999-02-26

Regulatory Status

RX

2004
30 Jul
RX Application: 40583

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2004-07-30

40583 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40583

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2004-07-30

Regulatory Status

RX

2004
30 Jul
RX Application: 40583

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2004-07-30

40583 / 2

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40583

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2004-07-30

Regulatory Status

RX

2004
12 Aug
RX Application: 40612

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2004-08-12

40612 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40612

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2004-08-12

Regulatory Status

RX

2013
19 Apr
RX Application: 91392

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2013-04-19

91392 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

91392

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2013-04-19

Regulatory Status

RX

2010
25 Oct
RX Application: 91045

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2010-10-25

91045 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

91045

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2010-10-25

Regulatory Status

RX

2019
17 May
RX Application: 207344

Drug Name

MICAFUNGIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2019-05-17

207344 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

207344

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 207344

Drug Name

MICAFUNGIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2019-05-17

207344 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

207344

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2019-05-17

Regulatory Status

RX

2000
20 Jun
RX Application: 75154

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75154 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75154

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75154

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75154 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75154

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2014
22 Aug
RX Application: 203460

Drug Name

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2014-08-22

203460 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

203460

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2014-08-22

Regulatory Status

RX

2014
22 Aug
RX Application: 203460

Drug Name

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2014-08-22

203460 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

203460

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2014-08-22

Regulatory Status

RX

2002
28 May
RX Application: 75936

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

75936 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75936

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

Regulatory Status

RX

2024
05 Apr
RX Application: 211269

Drug Name

MITOMYCIN

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

2024-04-05

211269 / 1

Active Ingredient

MITOMYCIN

Application Number

211269

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

2024-04-05

Regulatory Status

RX

2024
05 Apr
RX Application: 211269

Drug Name

MITOMYCIN

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2024-04-05

211269 / 2

Active Ingredient

MITOMYCIN

Application Number

211269

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2024-04-05

Regulatory Status

RX

2024
05 Apr
RX Application: 211269

Drug Name

MITOMYCIN

Product Number

3

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2024-04-05

211269 / 3

Active Ingredient

MITOMYCIN

Application Number

211269

Product Number

3

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2024-04-05

Regulatory Status

RX

2006
11 Apr
RX Application: 77496

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

77496 / 1

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

77496

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

Regulatory Status

RX

2006
11 Apr
RX Application: 77496

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

77496 / 2

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

77496

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

Regulatory Status

RX

2006
11 Apr
RX Application: 77496

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/15ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

77496 / 3

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

77496

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/15ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

Regulatory Status

RX

2013
30 Oct
RX Application: 204223

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

2MG/ML (2MG/ML)

Approval Date

2013-10-30

204223 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

204223

Product Number

1

Dosage Form

-

Strength

2MG/ML (2MG/ML)

Approval Date

2013-10-30

Regulatory Status

RX

2013
30 Oct
RX Application: 204223

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

4MG/ML (4MG/ML)

Approval Date

2013-10-30

204223 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

204223

Product Number

2

Dosage Form

-

Strength

4MG/ML (4MG/ML)

Approval Date

2013-10-30

Regulatory Status

RX

2013
30 Oct
RX Application: 204223

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2013-10-30

204223 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

204223

Product Number

5

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2013-10-30

Regulatory Status

RX

2015
03 Apr
RX Application: 205572

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)

Approval Date

2015-04-03

205572 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

205572

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)

Approval Date

2015-04-03

Regulatory Status

RX

2022
08 Jun
RX Application: 215371

Drug Name

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4

Product Number

1

Dosage Form

-

Strength

30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML

Approval Date

2022-06-08

215371 / 1

Active Ingredient

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

Application Number

215371

Product Number

1

Dosage Form

-

Strength

30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML

Approval Date

2022-06-08

Regulatory Status

RX

2024
02 Apr
RX Application: 213573

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2024-04-02

213573 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

213573

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2024-04-02

Regulatory Status

RX

2024
02 Apr
RX Application: 213573

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-04-02

213573 / 2

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

213573

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-04-02

Regulatory Status

RX

1998
01 May
RX Application: 20533

Drug Name

NAROPIN

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

1998-05-01

20533 / 1

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

1998-05-01

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

2

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

1996-09-24

20533 / 2

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

2

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

1998
01 May
RX Application: 20533

Drug Name

NAROPIN

Product Number

3

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

1998-05-01

20533 / 3

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

3

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

1998-05-01

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

4

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

1996-09-24

20533 / 4

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

4

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

5

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

1996-09-24

20533 / 5

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

5

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

6

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

1996-09-24

20533 / 6

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

6

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

7

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

1996-09-24

20533 / 7

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

7

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

8

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

1996-09-24

20533 / 8

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

8

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

2011
04 Jan
RX Application: 20533

Drug Name

NAROPIN

Product Number

9

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2011-01-04

20533 / 9

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

9

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2011-01-04

Regulatory Status

RX

2011
04 Jan
RX Application: 20533

Drug Name

NAROPIN

Product Number

10

Dosage Form

-

Strength

1GM/200ML (5MG/ML)

Approval Date

2011-01-04

20533 / 10

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

10

Dosage Form

-

Strength

1GM/200ML (5MG/ML)

Approval Date

2011-01-04

Regulatory Status

RX

1996
24 Sep
RX Application: 20533

Drug Name

NAROPIN

Product Number

11

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

1996-09-24

20533 / 11

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

20533

Product Number

11

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

1996-09-24

Regulatory Status

RX

1989
15 Jun
RX Application: 19887

Drug Name

NEBUPENT

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1989-06-15

19887 / 1

Active Ingredient

PENTAMIDINE ISETHIONATE

Application Number

19887

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1989-06-15

Regulatory Status

RX

2015
08 Jan
RX Application: 203629

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

1

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2015-01-08

203629 / 1

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

203629

Product Number

1

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2015-01-08

Regulatory Status

RX

2015
08 Jan
RX Application: 203629

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2015-01-08

203629 / 2

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

203629

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2015-01-08

Regulatory Status

RX

2018
18 Sep
RX Application: 203629

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

3

Dosage Form

-

Strength

3MG/3ML (1MG/ML)

Approval Date

2018-09-18

203629 / 3

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

203629

Product Number

3

Dosage Form

-

Strength

3MG/3ML (1MG/ML)

Approval Date

2018-09-18

Regulatory Status

RX

1982
01 Jan
RX Application: 9435

Drug Name

NESACAINE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

9435 / 2

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

9435

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

RX

1996
02 May
RX Application: 9435

Drug Name

NESACAINE-MPF

Product Number

6

Dosage Form

-

Strength

2%

Approval Date

1996-05-02

9435 / 6

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

9435

Product Number

6

Dosage Form

-

Strength

2%

Approval Date

1996-05-02

Regulatory Status

RX

1996
02 May
RX Application: 9435

Drug Name

NESACAINE-MPF

Product Number

7

Dosage Form

-

Strength

3%

Approval Date

1996-05-02

9435 / 7

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

9435

Product Number

7

Dosage Form

-

Strength

3%

Approval Date

1996-05-02

Regulatory Status

RX

2026
04 Aug
RX Application: 219334

Drug Name

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2026-08-04

219334 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

219334

Product Number

1

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2026-08-04

Regulatory Status

RX

2026
04 Aug
RX Application: 219334

Drug Name

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2026-08-04

219334 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

219334

Product Number

2

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2026-08-04

Regulatory Status

RX

2020
03 Nov
RX Application: 211382

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2020-11-03

211382 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

211382

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2020-11-03

Regulatory Status

RX

2006
10 Feb
RX Application: 77450

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2006-02-10

77450 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77450

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2006-02-10

Regulatory Status

RX

2006
10 Feb
RX Application: 77450

Drug Name

OCTREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2006-02-10

77450 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77450

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2006-02-10

Regulatory Status

RX

2006
10 Feb
RX Application: 77457

Drug Name

OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2006-02-10

77457 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77457

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2006-02-10

Regulatory Status

RX

2006
10 Feb
RX Application: 77457

Drug Name

OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2006-02-10

77457 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77457

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2006-02-10

Regulatory Status

RX

2006
10 Feb
RX Application: 77457

Drug Name

OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2006-02-10

77457 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77457

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2006-02-10

Regulatory Status

RX

2018
27 Jul
RX Application: 210589

Drug Name

OMEGAVEN

Product Number

1

Dosage Form

-

Strength

5GM/50ML (0.1GM/ML)

Approval Date

2018-07-27

210589 / 1

Active Ingredient

FISH OIL TRIGLYCERIDES

Application Number

210589

Product Number

1

Dosage Form

-

Strength

5GM/50ML (0.1GM/ML)

Approval Date

2018-07-27

Regulatory Status

RX

2018
27 Jul
RX Application: 210589

Drug Name

OMEGAVEN

Product Number

2

Dosage Form

-

Strength

10GM/100ML (0.1GM/ML)

Approval Date

2018-07-27

210589 / 2

Active Ingredient

FISH OIL TRIGLYCERIDES

Application Number

210589

Product Number

2

Dosage Form

-

Strength

10GM/100ML (0.1GM/ML)

Approval Date

2018-07-27

Regulatory Status

RX

2006
26 Dec
RX Application: 76974

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76974 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76974

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2006
26 Dec
RX Application: 76972

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76972 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76972

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2013
19 Jul
RX Application: 202253

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2013-07-19

202253 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

202253

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2013-07-19

Regulatory Status

RX

2020
20 Jul
RX Application: 206198

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2020-07-20

206198 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

206198

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2020-07-20

Regulatory Status

RX

2020
20 Jul
RX Application: 206198

Drug Name

OXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2020-07-20

206198 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

206198

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2020-07-20

Regulatory Status

RX

2020
27 Jul
RX Application: 206199

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2020-07-27

206199 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

206199

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2020-07-27

Regulatory Status

RX

2010
10 Jun
RX Application: 78811

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2010-06-10

78811 / 1

Active Ingredient

OXALIPLATIN

Application Number

78811

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2010-06-10

Regulatory Status

RX

2010
10 Jun
RX Application: 78811

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2010-06-10

78811 / 2

Active Ingredient

OXALIPLATIN

Application Number

78811

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2010-06-10

Regulatory Status

RX

2010
02 Jun
RX Application: 78819

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2010-06-02

78819 / 1

Active Ingredient

OXALIPLATIN

Application Number

78819

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2010-06-02

Regulatory Status

RX

2010
02 Jun
RX Application: 78819

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2010-06-02

78819 / 2

Active Ingredient

OXALIPLATIN

Application Number

78819

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2010-06-02

Regulatory Status

RX

1982
01 Jan
RX Application: 18248

Drug Name

OXYTOCIN

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML (10USP UNITS/ML)

Approval Date

1982-01-01

18248 / 1

Active Ingredient

OXYTOCIN

Application Number

18248

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML (10USP UNITS/ML)

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18248

Drug Name

OXYTOCIN

Product Number

2

Dosage Form

-

Strength

100USP UNITS/10ML (10USP UNITS/ML)

Approval Date

1982-01-01

18248 / 2

Active Ingredient

OXYTOCIN

Application Number

18248

Product Number

2

Dosage Form

-

Strength

100USP UNITS/10ML (10USP UNITS/ML)

Approval Date

1982-01-01

Regulatory Status

RX

2007
27 Jul
RX Application: 18248

Drug Name

OXYTOCIN

Product Number

3

Dosage Form

-

Strength

300USP UNITS/30ML (10USP UNITS/ML)

Approval Date

2007-07-27

18248 / 3

Active Ingredient

OXYTOCIN

Application Number

18248

Product Number

3

Dosage Form

-

Strength

300USP UNITS/30ML (10USP UNITS/ML)

Approval Date

2007-07-27

Regulatory Status

RX

2006
27 Nov
RX Application: 77574

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2006-11-27

77574 / 1

Active Ingredient

PACLITAXEL

Application Number

77574

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2006-11-27

Regulatory Status

RX

2018
19 Sep
RX Application: 206801

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

206801 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

206801

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

Regulatory Status

RX

2018
19 Sep
RX Application: 206802

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

206802 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

206802

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

Regulatory Status

RX

2024
01 Aug
RX Application: 216021

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2024-08-01

216021 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

216021

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2024-08-01

Regulatory Status

RX

2022
25 May
RX Application: 90384

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

90384 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

90384

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
RX Application: 90384

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

90384 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

90384

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
RX Application: 90384

Drug Name

PEMETREXED DISODIUM

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2022-05-25

90384 / 3

Active Ingredient

PEMETREXED DISODIUM

Application Number

90384

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
RX Application: 90384

Drug Name

PEMETREXED DISODIUM

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

90384 / 4

Active Ingredient

PEMETREXED DISODIUM

Application Number

90384

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

1984
16 Oct
RX Application: 19264

Drug Name

PENTAM

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1984-10-16

19264 / 1

Active Ingredient

PENTAMIDINE ISETHIONATE

Application Number

19264

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1984-10-16

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

PERIKABIVEN IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

Approval Date

2014-08-25

200656 / 1

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

1

Dosage Form

-

Strength

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

PERIKABIVEN IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

Approval Date

2014-08-25

200656 / 2

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

2

Dosage Form

-

Strength

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

Approval Date

2014-08-25

Regulatory Status

RX

2014
25 Aug
RX Application: 200656

Drug Name

PERIKABIVEN IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

Approval Date

2014-08-25

200656 / 3

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

Application Number

200656

Product Number

3

Dosage Form

-

Strength

2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

Approval Date

2014-08-25

Regulatory Status

RX

2019
29 Jan
RX Application: 210665

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2019-01-29

210665 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

210665

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2019-01-29

Regulatory Status

RX

2019
30 Jan
RX Application: 210666

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2019-01-30

210666 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

210666

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2019-01-30

Regulatory Status

RX

2019
30 Jan
RX Application: 210666

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2019-01-30

210666 / 2

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

210666

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2019-01-30

Regulatory Status

RX

1986
01 Dec
RX Application: 89407

Drug Name

POLOCAINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1986-12-01

89407 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

89407

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1986-12-01

Regulatory Status

RX

1986
01 Dec
RX Application: 89410

Drug Name

POLOCAINE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1986-12-01

89410 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

89410

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1986-12-01

Regulatory Status

RX

1986
01 Dec
RX Application: 89406

Drug Name

POLOCAINE-MPF

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1986-12-01

89406 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

89406

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1986-12-01

Regulatory Status

RX

1986
01 Dec
RX Application: 89408

Drug Name

POLOCAINE-MPF

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1986-12-01

89408 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

89408

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1986-12-01

Regulatory Status

RX

1986
01 Dec
RX Application: 89409

Drug Name

POLOCAINE-MPF

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1986-12-01

89409 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

89409

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1986-12-01

Regulatory Status

RX

2008
10 Jan
RX Application: 65372

Drug Name

POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

2008-01-10

65372 / 1

Active Ingredient

POLYMYXIN B SULFATE

Application Number

65372

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

2008-01-10

Regulatory Status

RX

2023
26 Dec
RX Application: 209983

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

300MG/16.7ML (18MG/ML)

Approval Date

2023-12-26

209983 / 1

Active Ingredient

POSACONAZOLE

Application Number

209983

Product Number

1

Dosage Form

-

Strength

300MG/16.7ML (18MG/ML)

Approval Date

2023-12-26

Regulatory Status

RX

2024
27 Nov
RX Application: 217515

Drug Name

POTASSIUM ACETATE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

2024-11-27

217515 / 1

Active Ingredient

POTASSIUM ACETATE

Application Number

217515

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

2024-11-27

Regulatory Status

RX

2020
17 Sep
RX Application: 212347

Drug Name

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%

Product Number

1

Dosage Form

-

Strength

150MG/100ML;450MG/100ML

Approval Date

2020-09-17

212347 / 1

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

212347

Product Number

1

Dosage Form

-

Strength

150MG/100ML;450MG/100ML

Approval Date

2020-09-17

Regulatory Status

RX

2021
02 Jun
RX Application: 212347

Drug Name

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%

Product Number

3

Dosage Form

-

Strength

150MG/100ML;900MG/100ML

Approval Date

2021-06-02

212347 / 3

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

212347

Product Number

3

Dosage Form

-

Strength

150MG/100ML;900MG/100ML

Approval Date

2021-06-02

Regulatory Status

RX

2020
17 Sep
RX Application: 212347

Drug Name

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

300MG/100ML;900MG/100ML

Approval Date

2020-09-17

212347 / 2

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

212347

Product Number

2

Dosage Form

-

Strength

300MG/100ML;900MG/100ML

Approval Date

2020-09-17

Regulatory Status

RX

2020
09 Sep
RX Application: 211087

Drug Name

POTASSIUM CHLORIDE 10MEQ

Product Number

1

Dosage Form

-

Strength

14.9MG/ML

Approval Date

2020-09-09

211087 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211087

Product Number

1

Dosage Form

-

Strength

14.9MG/ML

Approval Date

2020-09-09

Regulatory Status

RX

2020
09 Sep
RX Application: 211087

Drug Name

POTASSIUM CHLORIDE 10MEQ

Product Number

2

Dosage Form

-

Strength

746MG/100ML

Approval Date

2020-09-09

211087 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211087

Product Number

2

Dosage Form

-

Strength

746MG/100ML

Approval Date

2020-09-09

Regulatory Status

RX

2021
30 Jul
RX Application: 212348

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;225MG/100ML

Approval Date

2021-07-30

212348 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

212348

Product Number

1

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;225MG/100ML

Approval Date

2021-07-30

Regulatory Status

RX

2021
09 Mar
RX Application: 213523

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Product Number

1

Dosage Form

-

Strength

5GM/100ML;74.5MG/100ML;450MG/100ML

Approval Date

2021-03-09

213523 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213523

Product Number

1

Dosage Form

-

Strength

5GM/100ML;74.5MG/100ML;450MG/100ML

Approval Date

2021-03-09

Regulatory Status

RX

2022
11 Oct
RX Application: 213523

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Product Number

5

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;450MG/100ML

Approval Date

2022-10-11

213523 / 5

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213523

Product Number

5

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;450MG/100ML

Approval Date

2022-10-11

Regulatory Status

RX

2020
09 Sep
RX Application: 211087

Drug Name

POTASSIUM CHLORIDE 20MEQ

Product Number

3

Dosage Form

-

Strength

29.8MG/ML

Approval Date

2020-09-09

211087 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211087

Product Number

3

Dosage Form

-

Strength

29.8MG/ML

Approval Date

2020-09-09

Regulatory Status

RX

2021
07 May
RX Application: 211087

Drug Name

POTASSIUM CHLORIDE 20MEQ

Product Number

5

Dosage Form

-

Strength

1.49GM/100ML

Approval Date

2021-05-07

211087 / 5

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211087

Product Number

5

Dosage Form

-

Strength

1.49GM/100ML

Approval Date

2021-05-07

Regulatory Status

RX

2021
30 Jul
RX Application: 212348

Drug Name

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;225MG/100ML

Approval Date

2021-07-30

212348 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

212348

Product Number

2

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;225MG/100ML

Approval Date

2021-07-30

Regulatory Status

RX

2021
09 Mar
RX Application: 213523

Drug Name

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Product Number

2

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;450MG/100ML

Approval Date

2021-03-09

213523 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213523

Product Number

2

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;450MG/100ML

Approval Date

2021-03-09

Regulatory Status

RX

2021
09 Mar
RX Application: 213445

Drug Name

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;900MG/100ML

Approval Date

2021-03-09

213445 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213445

Product Number

1

Dosage Form

-

Strength

5GM/100ML;149MG/100ML;900MG/100ML

Approval Date

2021-03-09

Regulatory Status

RX

2021
09 Mar
RX Application: 213523

Drug Name

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Product Number

3

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;450MG/100ML

Approval Date

2021-03-09

213523 / 3

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213523

Product Number

3

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;450MG/100ML

Approval Date

2021-03-09

Regulatory Status

RX

2020
09 Sep
RX Application: 211087

Drug Name

POTASSIUM CHLORIDE 40MEQ

Product Number

4

Dosage Form

-

Strength

2.98GM/100ML

Approval Date

2020-09-09

211087 / 4

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211087

Product Number

4

Dosage Form

-

Strength

2.98GM/100ML

Approval Date

2020-09-09

Regulatory Status

RX

2021
09 Mar
RX Application: 213523

Drug Name

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Product Number

4

Dosage Form

-

Strength

5GM/100ML;298MG/100ML;450MG/100ML

Approval Date

2021-03-09

213523 / 4

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213523

Product Number

4

Dosage Form

-

Strength

5GM/100ML;298MG/100ML;450MG/100ML

Approval Date

2021-03-09

Regulatory Status

RX

2021
09 Mar
RX Application: 213445

Drug Name

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

5GM/100ML;298MG/100ML;900MG/100ML

Approval Date

2021-03-09

213445 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

213445

Product Number

2

Dosage Form

-

Strength

5GM/100ML;298MG/100ML;900MG/100ML

Approval Date

2021-03-09

Regulatory Status

RX

1985
25 Jan
RX Application: 88901

Drug Name

POTASSIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1985-01-25

88901 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

88901

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1985-01-25

Regulatory Status

RX

1985
25 Jan
RX Application: 88908

Drug Name

POTASSIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1985-01-25

88908 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

88908

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1985-01-25

Regulatory Status

RX

2019
26 Nov
RX Application: 212832

Drug Name

POTASSIUM PHOSPHATES

Product Number

1

Dosage Form

-

Strength

1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)

Approval Date

2019-11-26

212832 / 1

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

212832

Product Number

1

Dosage Form

-

Strength

1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)

Approval Date

2019-11-26

Regulatory Status

RX

2019
26 Nov
RX Application: 212832

Drug Name

POTASSIUM PHOSPHATES

Product Number

2

Dosage Form

-

Strength

3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

Approval Date

2019-11-26

212832 / 2

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

212832

Product Number

2

Dosage Form

-

Strength

3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

Approval Date

2019-11-26

Regulatory Status

RX

2019
26 Nov
RX Application: 212832

Drug Name

POTASSIUM PHOSPHATES

Product Number

3

Dosage Form

-

Strength

11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)

Approval Date

2019-11-26

212832 / 3

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

212832

Product Number

3

Dosage Form

-

Strength

11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)

Approval Date

2019-11-26

Regulatory Status

RX

2025
09 May
RX Application: 212832

Drug Name

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE

Product Number

4

Dosage Form

-

Strength

1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)

Approval Date

2025-05-09

212832 / 4

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

212832

Product Number

4

Dosage Form

-

Strength

1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)

Approval Date

2025-05-09

Regulatory Status

RX

2025
09 May
RX Application: 212832

Drug Name

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE

Product Number

5

Dosage Form

-

Strength

1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)

Approval Date

2025-05-09

212832 / 5

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

212832

Product Number

5

Dosage Form

-

Strength

1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)

Approval Date

2025-05-09

Regulatory Status

RX

2001
25 Apr
RX Application: 75906

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2001-04-25

75906 / 1

Active Ingredient

PROGESTERONE

Application Number

75906

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2001-04-25

Regulatory Status

RX

2001
31 Aug
RX Application: 75826

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2001-08-31

75826 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

75826

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2001-08-31

Regulatory Status

RX

1987
07 Apr
RX Application: 89454

Drug Name

PROTAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

1987-04-07

89454 / 1

Active Ingredient

PROTAMINE SULFATE

Application Number

89454

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

1987-04-07

Regulatory Status

RX

1987
07 Apr
RX Application: 89454

Drug Name

PROTAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

250MG/25ML (10MG/ML)

Approval Date

1987-04-07

89454 / 2

Active Ingredient

PROTAMINE SULFATE

Application Number

89454

Product Number

2

Dosage Form

-

Strength

250MG/25ML (10MG/ML)

Approval Date

1987-04-07

Regulatory Status

RX

1982
01 Jan
RX Application: 80618

Drug Name

PYRIDOXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

80618 / 1

Active Ingredient

PYRIDOXINE HYDROCHLORIDE

Application Number

80618

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2018
16 Jan
RX Application: 206223

Drug Name

REMIFENTANIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2018-01-16

206223 / 1

Active Ingredient

REMIFENTANIL HYDROCHLORIDE

Application Number

206223

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2018-01-16

Regulatory Status

RX

2018
16 Jan
RX Application: 206223

Drug Name

REMIFENTANIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/VIAL

Approval Date

2018-01-16

206223 / 2

Active Ingredient

REMIFENTANIL HYDROCHLORIDE

Application Number

206223

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/VIAL

Approval Date

2018-01-16

Regulatory Status

RX

2018
16 Jan
RX Application: 206223

Drug Name

REMIFENTANIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE/VIAL

Approval Date

2018-01-16

206223 / 3

Active Ingredient

REMIFENTANIL HYDROCHLORIDE

Application Number

206223

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE/VIAL

Approval Date

2018-01-16

Regulatory Status

RX

2014
21 Aug
RX Application: 91181

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2014-08-21

91181 / 1

Active Ingredient

RIFAMPIN

Application Number

91181

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2014-08-21

Regulatory Status

RX

2008
29 Dec
RX Application: 78651

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-12-29

78651 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78651

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-12-29

Regulatory Status

RX

2008
29 Dec
RX Application: 78651

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-12-29

78651 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78651

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-12-29

Regulatory Status

RX

2025
09 Jun
RX Application: 217472

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2025-06-09

217472 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

217472

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2025-06-09

Regulatory Status

RX

2025
09 Jun
RX Application: 217472

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2025-06-09

217472 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

217472

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2025-06-09

Regulatory Status

RX

2021
12 Oct
RX Application: 206254

Drug Name

ROMIDEPSIN

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2021-10-12

206254 / 1

Active Ingredient

ROMIDEPSIN

Application Number

206254

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2021-10-12

Regulatory Status

RX

1982
01 Jan
RX Application: 18304

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

18304 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18304

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18304

Drug Name

SENSORCAINE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

18304 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18304

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18304

Drug Name

SENSORCAINE

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

18304 / 3

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18304

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

Regulatory Status

RX

1983
02 Sep
RX Application: 18304

Drug Name

SENSORCAINE

Product Number

4

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1983-09-02

18304 / 4

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

18304

Product Number

4

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1983-09-02

Regulatory Status

RX

1983
02 Sep
RX Application: 18304

Drug Name

SENSORCAINE

Product Number

5

Dosage Form

-

Strength

0.75%;0.0091MG/ML

Approval Date

1983-09-02

18304 / 5

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

18304

Product Number

5

Dosage Form

-

Strength

0.75%;0.0091MG/ML

Approval Date

1983-09-02

Regulatory Status

RX

1986
21 May
RX Application: 70552

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1986-05-21

70552 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70552

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1986-05-21

Regulatory Status

RX

1986
21 May
RX Application: 70553

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1986-05-21

70553 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70553

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1986-05-21

Regulatory Status

RX

1986
21 May
RX Application: 70554

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1986-05-21

70554 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70554

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1986-05-21

Regulatory Status

RX

1987
13 Oct
RX Application: 70966

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1987-10-13

70966 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

70966

Product Number

1

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1987-10-13

Regulatory Status

RX

1987
13 Oct
RX Application: 70967

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1987-10-13

70967 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

70967

Product Number

1

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1987-10-13

Regulatory Status

RX

1987
13 Oct
RX Application: 70968

Drug Name

SENSORCAINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1987-10-13

70968 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

70968

Product Number

1

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1987-10-13

Regulatory Status

RX

2016
13 Jul
RX Application: 207648

Drug Name

SMOFLIPID 20%

Product Number

1

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)

Approval Date

2016-07-13

207648 / 1

Active Ingredient

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

Application Number

207648

Product Number

1

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 207648

Drug Name

SMOFLIPID 20%

Product Number

2

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)

Approval Date

2016-07-13

207648 / 2

Active Ingredient

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

Application Number

207648

Product Number

2

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 207648

Drug Name

SMOFLIPID 20%

Product Number

3

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)

Approval Date

2016-07-13

207648 / 3

Active Ingredient

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

Application Number

207648

Product Number

3

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)

Approval Date

2016-07-13

Regulatory Status

RX

2018
10 Aug
RX Application: 207648

Drug Name

SMOFLIPID 20%

Product Number

4

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)

Approval Date

2018-08-10

207648 / 4

Active Ingredient

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

Application Number

207648

Product Number

4

Dosage Form

-

Strength

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)

Approval Date

2018-08-10

Regulatory Status

RX

2017
30 Oct
RX Application: 206687

Drug Name

SODIUM ACETATE

Product Number

1

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2017-10-30

206687 / 1

Active Ingredient

SODIUM ACETATE

Application Number

206687

Product Number

1

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2017-10-30

Regulatory Status

RX

2025
25 Aug
RX Application: 206688

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Approval Date

2025-08-25

206688 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

206688

Product Number

1

Dosage Form

-

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Approval Date

2025-08-25

Regulatory Status

RX

2025
25 Aug
RX Application: 206688

Drug Name

SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2025-08-25

206688 / 2

Active Ingredient

SODIUM BICARBONATE

Application Number

206688

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2025-08-25

Regulatory Status

RX

2018
23 Jul
RX Application: 208122

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

2018-07-23

208122 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

208122

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

2018-07-23

Regulatory Status

RX

1985
10 Jan
RX Application: 88912

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1985-01-10

88912 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

88912

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1985-01-10

Regulatory Status

RX

1985
10 Jan
RX Application: 88912

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1985-01-10

88912 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

88912

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1985-01-10

Regulatory Status

RX

1985
10 Jan
RX Application: 88912

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1985-01-10

88912 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

88912

Product Number

3

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1985-01-10

Regulatory Status

RX

1985
29 Nov
RX Application: 88912

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

18MG/2ML (9MG/ML)

Approval Date

1985-11-29

88912 / 4

Active Ingredient

SODIUM CHLORIDE

Application Number

88912

Product Number

4

Dosage Form

-

Strength

18MG/2ML (9MG/ML)

Approval Date

1985-11-29

Regulatory Status

RX

2017
19 Sep
RX Application: 207310

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

2017-09-19

207310 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

207310

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

2017-09-19

Regulatory Status

RX

2024
24 Jun
RX Application: 213688

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

2024-06-24

213688 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

213688

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

2024-06-24

Regulatory Status

RX

2021
28 Apr
RX Application: 212070

Drug Name

SODIUM CHLORIDE 14.6%

Product Number

1

Dosage Form

-

Strength

50MEQ/20ML (2.5MEQ/ML)

Approval Date

2021-04-28

212070 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

212070

Product Number

1

Dosage Form

-

Strength

50MEQ/20ML (2.5MEQ/ML)

Approval Date

2021-04-28

Regulatory Status

RX

2021
28 Apr
RX Application: 212070

Drug Name

SODIUM CHLORIDE 14.6%

Product Number

2

Dosage Form

-

Strength

100MEQ/40ML (2.5MEQ/ML)

Approval Date

2021-04-28

212070 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

212070

Product Number

2

Dosage Form

-

Strength

100MEQ/40ML (2.5MEQ/ML)

Approval Date

2021-04-28

Regulatory Status

RX

2022
14 Feb
RX Application: 212070

Drug Name

SODIUM CHLORIDE 23.4%

Product Number

3

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2022-02-14

212070 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

212070

Product Number

3

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2022-02-14

Regulatory Status

RX

2021
28 Apr
RX Application: 212248

Drug Name

SODIUM CHLORIDE 23.4%

Product Number

1

Dosage Form

-

Strength

234MG/ML

Approval Date

2021-04-28

212248 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

212248

Product Number

1

Dosage Form

-

Strength

234MG/ML

Approval Date

2021-04-28

Regulatory Status

RX

2023
11 Jul
RX Application: 217796

Drug Name

SODIUM CHLORIDE 23.4%

Product Number

1

Dosage Form

-

Strength

234MG/ML

Approval Date

2023-07-11

217796 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

217796

Product Number

1

Dosage Form

-

Strength

234MG/ML

Approval Date

2023-07-11

Regulatory Status

RX

2019
13 Mar
RX Application: 209476

Drug Name

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

2019-03-13

209476 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

209476

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

2019-03-13

Regulatory Status

RX

2022
30 Mar
RX Application: 209997

Drug Name

SODIUM PHOSPHATES

Product Number

1

Dosage Form

-

Strength

1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)

Approval Date

2022-03-30

209997 / 1

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

209997

Product Number

1

Dosage Form

-

Strength

1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)

Approval Date

2022-03-30

Regulatory Status

RX

2022
30 Mar
RX Application: 209997

Drug Name

SODIUM PHOSPHATES

Product Number

2

Dosage Form

-

Strength

4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)

Approval Date

2022-03-30

209997 / 2

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

209997

Product Number

2

Dosage Form

-

Strength

4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)

Approval Date

2022-03-30

Regulatory Status

RX

2022
30 Mar
RX Application: 209997

Drug Name

SODIUM PHOSPHATES

Product Number

3

Dosage Form

-

Strength

13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)

Approval Date

2022-03-30

209997 / 3

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

209997

Product Number

3

Dosage Form

-

Strength

13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)

Approval Date

2022-03-30

Regulatory Status

RX

2017
24 Nov
RX Application: 209689

Drug Name

STERILE WATER FOR INJECTION

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2017-11-24

209689 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

209689

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2017-11-24

Regulatory Status

RX

1984
16 Jan
RX Application: 88400

Drug Name

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1984-01-16

88400 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

88400

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1984-01-16

Regulatory Status

RX

2024
12 Aug
RX Application: 216123

Drug Name

STERILE WATER FOR IRRIGATION

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2024-08-12

216123 / 1

Active Ingredient

STERILE WATER FOR IRRIGATION

Application Number

216123

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2024-08-12

Regulatory Status

RX

2020
20 Nov
RX Application: 211346

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-11-20

211346 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

211346

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-11-20

Regulatory Status

RX

2025
11 Feb
RX Application: 217884

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2025-02-11

217884 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

217884

Product Number

1

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2025-02-11

Regulatory Status

RX

2025
21 Feb
RX Application: 217885

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2025-02-21

217885 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

217885

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2025-02-21

Regulatory Status

RX

2026
28 Jul
RX Application: 219448

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

219448 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

219448

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2009
02 Mar
RX Application: 79242

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-03-02

79242 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

79242

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-03-02

Regulatory Status

RX

2004
26 May
RX Application: 76887

Drug Name

TERBUTALINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-05-26

76887 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

76887

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-05-26

Regulatory Status

RX

1982
01 Jan
RX Application: 80556

Drug Name

THIAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

80556 / 1

Active Ingredient

THIAMINE HYDROCHLORIDE

Application Number

80556

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2004
13 Jul
RX Application: 50789

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL

Approval Date

2004-07-13

50789 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

50789

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL

Approval Date

2004-07-13

Regulatory Status

RX

2002
29 Nov
RX Application: 65122

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2002-11-29

65122 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

65122

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2002-11-29

Regulatory Status

RX

2002
29 Nov
RX Application: 65122

Drug Name

TOBRAMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2002-11-29

65122 / 2

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

65122

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2002-11-29

Regulatory Status

RX

2002
29 Nov
RX Application: 65120

Drug Name

TOBRAMYCIN SULFATE (PHARMACY BULK)

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2002-11-29

65120 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

65120

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2002-11-29

Regulatory Status

RX

2010
29 Nov
RX Application: 91089

Drug Name

TOPOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

2010-11-29

91089 / 1

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

91089

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

2010-11-29

Regulatory Status

RX

2024
15 Aug
RX Application: 218242

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2024-08-15

218242 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

218242

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2024-08-15

Regulatory Status

RX

2003
26 Jun
RX Application: 76539

Drug Name

VALPROATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2003-06-26

76539 / 1

Active Ingredient

VALPROATE SODIUM

Application Number

76539

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2003-06-26

Regulatory Status

RX

1987
17 Mar
RX Application: 62663

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-03-17

62663 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62663

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-03-17

Regulatory Status

RX

1987
31 Jul
RX Application: 62663

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-07-31

62663 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62663

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-07-31

Regulatory Status

RX

1988
03 Jun
RX Application: 62663

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1988-06-03

62663 / 3

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62663

Product Number

3

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1988-06-03

Regulatory Status

RX

1997
28 Nov
RX Application: 62663

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1997-11-28

62663 / 4

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62663

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1997-11-28

Regulatory Status

RX

2016
17 Aug
RX Application: 62663

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2016-08-17

62663 / 5

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62663

Product Number

5

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2016-08-17

Regulatory Status

RX

2023
26 May
RX Application: 213206

Drug Name

VASOPRESSIN

Product Number

1

Dosage Form

-

Strength

20UNITS/ML (20UNITS/ML)

Approval Date

2023-05-26

213206 / 1

Active Ingredient

VASOPRESSIN

Application Number

213206

Product Number

1

Dosage Form

-

Strength

20UNITS/ML (20UNITS/ML)

Approval Date

2023-05-26

Regulatory Status

RX

2024
23 Apr
RX Application: 216471

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2024-04-23

216471 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

216471

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2024-04-23

Regulatory Status

RX

1982
01 Jan
RX Application: 80557

Drug Name

VIBISONE

Product Number

3

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

80557 / 3

Active Ingredient

CYANOCOBALAMIN

Application Number

80557

Product Number

3

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1987
29 Apr
RX Application: 89515

Drug Name

VINBLASTINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1987-04-29

89515 / 1

Active Ingredient

VINBLASTINE SULFATE

Application Number

89515

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1987-04-29

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

6488 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE

Product Number

7

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

6488 / 7

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

7

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE

Product Number

8

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

6488 / 8

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

8

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE

Product Number

10

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

6488 / 10

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

10

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

4

Dosage Form

-

Strength

0.01MG/ML;1%

Approval Date

1982-01-01

6488 / 4

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

4

Dosage Form

-

Strength

0.01MG/ML;1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

5

Dosage Form

-

Strength

0.02MG/ML;2%

Approval Date

1982-01-01

6488 / 5

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

5

Dosage Form

-

Strength

0.02MG/ML;2%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

12

Dosage Form

-

Strength

0.005MG/ML;0.5%

Approval Date

1982-01-01

6488 / 12

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

12

Dosage Form

-

Strength

0.005MG/ML;0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 6488

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

17

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1982-01-01

6488 / 17

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

17

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1982-01-01

Regulatory Status

RX

1986
13 Nov
RX Application: 6488

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

18

Dosage Form

-

Strength

0.005MG/ML;1%

Approval Date

1986-11-13

6488 / 18

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

18

Dosage Form

-

Strength

0.005MG/ML;1%

Approval Date

1986-11-13

Regulatory Status

RX

1986
13 Nov
RX Application: 6488

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

19

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1986-11-13

6488 / 19

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

6488

Product Number

19

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1986-11-13

Regulatory Status

RX

2022
27 Dec
RX Application: 216145

Drug Name

ZINC SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

Approval Date

2022-12-27

216145 / 1

Active Ingredient

ZINC SULFATE

Application Number

216145

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

Approval Date

2022-12-27

Regulatory Status

RX

2022
27 Dec
RX Application: 216145

Drug Name

ZINC SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

Approval Date

2022-12-27

216145 / 2

Active Ingredient

ZINC SULFATE

Application Number

216145

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

Approval Date

2022-12-27

Regulatory Status

RX

2022
27 Dec
RX Application: 216145

Drug Name

ZINC SULFATE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

Approval Date

2022-12-27

216145 / 3

Active Ingredient

ZINC SULFATE

Application Number

216145

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

Approval Date

2022-12-27

Regulatory Status

RX

2015
23 Apr
RX Application: 91516

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2015-04-23

91516 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

91516

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2015-04-23

Regulatory Status

RX

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Drug Status Breakdown
417 total
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETAMINOPHEN

Application Number

204767

Product Number

1

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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