Hospira, Inc. RX
FDA Approved Drugs

Hospira, Inc. RX

FDA Approved Drugs Database

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

RX
  • Total Records 288
  • Latest Approval Date Sep 11, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
863
View
Unclassified
14
View
Discontinued
561
View
RX
288
View
Company Overview

Company

Hospira, Inc. RX

Country

U.S.A

Website

Visit Website

Email

supportservices@hospira.com

Social Profiles

LinkedIn
Company Snapshot

Hospira, Inc. RX

275 North Field Drive, Lake Forest, Illinois

U.S.A

www.pfizerhospitalus.com/ supportservices@hospira.com View on Map
FDA Approved Drug Records ( 288 records )
1994
30 Aug
RX Application: 73664

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1994-08-30

73664 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

73664

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1994-08-30

Regulatory Status

RX

1994
30 Aug
RX Application: 74037

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1994-08-30

74037 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

74037

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1994-08-30

Regulatory Status

RX

1982
07 Sep
RX Application: 18227

Drug Name

AMIDATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-09-07

18227 / 1

Active Ingredient

ETOMIDATE

Application Number

18227

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-09-07

Regulatory Status

RX

1987
09 Mar
RX Application: 70010

Drug Name

AMINOCAPROIC ACID IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1987-03-09

70010 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

70010

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1987-03-09

Regulatory Status

RX

1983
26 Oct
RX Application: 87242

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1983-10-26

87242 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

87242

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1983-10-26

Regulatory Status

RX

1984
13 Jun
RX Application: 88366

Drug Name

AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5MEQ/ML

Approval Date

1984-06-13

88366 / 1

Active Ingredient

AMMONIUM CHLORIDE

Application Number

88366

Product Number

1

Dosage Form

-

Strength

5MEQ/ML

Approval Date

1984-06-13

Regulatory Status

RX

2016
21 Sep
RX Application: 204120

Drug Name

ARGATROBAN

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2016-09-21

204120 / 1

Active Ingredient

ARGATROBAN

Application Number

204120

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2016-09-21

Regulatory Status

RX

2012
18 Oct
RX Application: 90761

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

90761 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

90761

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

Regulatory Status

RX

2012
18 Oct
RX Application: 90782

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

90782 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

90782

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

Regulatory Status

RX

2001
09 Jul
RX Application: 21146

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2001-07-09

21146 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

21146

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2001-07-09

Regulatory Status

RX

2001
09 Jul
RX Application: 21146

Drug Name

ATROPINE SULFATE

Product Number

2

Dosage Form

-

Strength

0.25MG/5ML (0.05MG/ML)

Approval Date

2001-07-09

21146 / 2

Active Ingredient

ATROPINE SULFATE

Application Number

21146

Product Number

2

Dosage Form

-

Strength

0.25MG/5ML (0.05MG/ML)

Approval Date

2001-07-09

Regulatory Status

RX

2001
09 Jul
RX Application: 21146

Drug Name

ATROPINE SULFATE

Product Number

3

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2001-07-09

21146 / 3

Active Ingredient

ATROPINE SULFATE

Application Number

21146

Product Number

3

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2001-07-09

Regulatory Status

RX

2009
26 Jun
RX Application: 65500

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-06-26

65500 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65500

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-06-26

Regulatory Status

RX

2021
08 Nov
RX Application: 206517

Drug Name

AZTREONAM

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2021-11-08

206517 / 1

Active Ingredient

AZTREONAM

Application Number

206517

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2021-11-08

Regulatory Status

RX

2021
08 Nov
RX Application: 206517

Drug Name

AZTREONAM

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2021-11-08

206517 / 2

Active Ingredient

AZTREONAM

Application Number

206517

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2021-11-08

Regulatory Status

RX

1982
29 Oct
RX Application: 18800

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

18800 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18800

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18800

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

18800 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

18800

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18800

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1982-10-29

18800 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

18800

Product Number

3

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
27 Oct
RX Application: 18802

Drug Name

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-10-27

18802 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18802

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-10-27

Regulatory Status

RX

2000
10 Mar
RX Application: 65031

Drug Name

BLEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2000-03-10

65031 / 1

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65031

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2000-03-10

Regulatory Status

RX

2000
10 Mar
RX Application: 65031

Drug Name

BLEOMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2000-03-10

65031 / 2

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65031

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2000-03-10

Regulatory Status

RX

2022
26 Jul
RX Application: 208460

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-07-26

208460 / 1

Active Ingredient

BORTEZOMIB

Application Number

208460

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-07-26

Regulatory Status

RX

2022
02 May
RX Application: 209191

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2022-05-02

209191 / 1

Active Ingredient

BORTEZOMIB

Application Number

209191

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

2022
02 May
RX Application: 209191

Drug Name

BORTEZOMIB

Product Number

2

Dosage Form

-

Strength

2.5MG/VIAL

Approval Date

2022-05-02

209191 / 2

Active Ingredient

BORTEZOMIB

Application Number

209191

Product Number

2

Dosage Form

-

Strength

2.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

1987
17 Feb
RX Application: 70583

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

70583 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70583

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

Regulatory Status

RX

1986
17 Feb
RX Application: 70584

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1986-02-17

70584 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70584

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1986-02-17

Regulatory Status

RX

1987
03 Mar
RX Application: 70585

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-03-03

70585 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70585

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-03-03

Regulatory Status

RX

1987
17 Feb
RX Application: 70590

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

70590 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70590

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

Regulatory Status

RX

1987
03 Mar
RX Application: 70597

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

70597 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70597

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

Regulatory Status

RX

1987
03 Mar
RX Application: 70609

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

70609 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70609

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

Regulatory Status

RX

1987
11 Dec
RX Application: 71810

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-12-11

71810 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

71810

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-12-11

Regulatory Status

RX

1988
16 Jun
RX Application: 71165

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

71165 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71165

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
RX Application: 71167

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

71167 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71167

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
RX Application: 71168

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

71168 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71168

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
RX Application: 71170

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

71170 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71170

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1996
03 Jun
RX Application: 74137

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML

Approval Date

1996-06-03

74137 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

74137

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML

Approval Date

1996-06-03

Regulatory Status

RX

2018
31 Jul
RX Application: 205672

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2018-07-31

205672 / 1

Active Ingredient

BUSULFAN

Application Number

205672

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2018-07-31

Regulatory Status

RX

1997
23 Jan
RX Application: 74626

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1997-01-23

74626 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

74626

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1997-01-23

Regulatory Status

RX

1997
23 Jan
RX Application: 74626

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1997-01-23

74626 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

74626

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1997-01-23

Regulatory Status

RX

2000
28 Jan
RX Application: 21117

Drug Name

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2000-01-28

21117 / 1

Active Ingredient

CALCIUM CHLORIDE

Application Number

21117

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2000-01-28

Regulatory Status

RX

2004
14 Oct
RX Application: 76517

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2004-10-14

76517 / 1

Active Ingredient

CARBOPLATIN

Application Number

76517

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2004-10-14

Regulatory Status

RX

2004
14 Oct
RX Application: 76517

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2004-10-14

76517 / 2

Active Ingredient

CARBOPLATIN

Application Number

76517

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2004-10-14

Regulatory Status

RX

2004
14 Oct
RX Application: 76517

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2004-10-14

76517 / 3

Active Ingredient

CARBOPLATIN

Application Number

76517

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2004-10-14

Regulatory Status

RX

2004
23 Nov
RX Application: 77059

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2004-11-23

77059 / 1

Active Ingredient

CARBOPLATIN

Application Number

77059

Product Number

1

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

1986
26 Jun
RX Application: 18961

Drug Name

CHROMIC CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.004MG CHROMIUM/ML

Approval Date

1986-06-26

18961 / 1

Active Ingredient

CHROMIC CHLORIDE

Application Number

18961

Product Number

1

Dosage Form

-

Strength

EQ 0.004MG CHROMIUM/ML

Approval Date

1986-06-26

Regulatory Status

RX

2008
18 Mar
RX Application: 77753

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

77753 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

77753

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

Regulatory Status

RX

2008
18 Mar
RX Application: 77753

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

77753 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

77753

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

Regulatory Status

RX

2018
30 Mar
RX Application: 203236

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

203236 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203236

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

Regulatory Status

RX

2018
30 Mar
RX Application: 203236

Drug Name

CISATRACURIUM BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2018-03-30

203236 / 2

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203236

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2018-03-30

Regulatory Status

RX

2018
30 Mar
RX Application: 203238

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

203238 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203238

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

Regulatory Status

RX

1986
26 Jun
RX Application: 18960

Drug Name

CUPRIC CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

1986-06-26

18960 / 1

Active Ingredient

CUPRIC CHLORIDE

Application Number

18960

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

1986-06-26

Regulatory Status

RX

1990
04 Jun
RX Application: 71868

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-06-04

71868 / 1

Active Ingredient

CYTARABINE

Application Number

71868

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-06-04

Regulatory Status

RX

1990
31 Aug
RX Application: 72168

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-08-31

72168 / 1

Active Ingredient

CYTARABINE

Application Number

72168

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-08-31

Regulatory Status

RX

1994
28 Feb
RX Application: 72945

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1994-02-28

72945 / 1

Active Ingredient

CYTARABINE

Application Number

72945

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1994-02-28

Regulatory Status

RX

1999
22 Nov
RX Application: 75383

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1999-11-22

75383 / 1

Active Ingredient

CYTARABINE

Application Number

75383

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1999-11-22

Regulatory Status

RX

2021
21 Jun
RX Application: 210282

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2021-06-21

210282 / 1

Active Ingredient

DAPTOMYCIN

Application Number

210282

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 210282

Drug Name

DAPTOMYCIN

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2021-06-21

210282 / 2

Active Ingredient

DAPTOMYCIN

Application Number

210282

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2021-06-21

Regulatory Status

RX

2004
17 Mar
RX Application: 76019

Drug Name

DEFEROXAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2004-03-17

76019 / 1

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

76019

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2004-03-17

Regulatory Status

RX

2004
17 Mar
RX Application: 76019

Drug Name

DEFEROXAMINE MESYLATE

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2004-03-17

76019 / 2

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

76019

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2004-03-17

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

21171 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

21171 / 2

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

3

Dosage Form

-

Strength

75MG/ML

Approval Date

1982-01-01

21171 / 3

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

3

Dosage Form

-

Strength

75MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

4

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

21171 / 4

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

4

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1998
23 Nov
RX Application: 19445

Drug Name

DEXTROSE 25%

Product Number

2

Dosage Form

-

Strength

250MG/ML

Approval Date

1998-11-23

19445 / 2

Active Ingredient

DEXTROSE

Application Number

19445

Product Number

2

Dosage Form

-

Strength

250MG/ML

Approval Date

1998-11-23

Regulatory Status

RX

1985
15 Jul
RX Application: 19466

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-07-15

19466 / 1

Active Ingredient

DEXTROSE

Application Number

19466

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-07-15

Regulatory Status

RX

1985
17 Sep
RX Application: 19479

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-09-17

19479 / 1

Active Ingredient

DEXTROSE

Application Number

19479

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-09-17

Regulatory Status

RX

1986
03 Jun
RX Application: 19445

Drug Name

DEXTROSE 50%

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1986-06-03

19445 / 1

Active Ingredient

DEXTROSE

Application Number

19445

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1986-06-03

Regulatory Status

RX

1987
13 Oct
RX Application: 71583

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

1987-10-13

71583 / 1

Active Ingredient

DIAZEPAM

Application Number

71583

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

1987-10-13

Regulatory Status

RX

1988
20 Dec
RX Application: 72079

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1988-12-20

72079 / 1

Active Ingredient

DIAZEPAM

Application Number

72079

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1988-12-20

Regulatory Status

RX

2002
17 Dec
RX Application: 75853

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2002-12-17

75853 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75853

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2002-12-17

Regulatory Status

RX

1993
29 Nov
RX Application: 74086

Drug Name

DOBUTAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1993-11-29

74086 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

74086

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1993-11-29

Regulatory Status

RX

1993
19 Oct
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

20201 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

20201 / 2

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

20201 / 3

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1994
07 Jul
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE/100ML

Approval Date

1994-07-07

20201 / 6

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE/100ML

Approval Date

1994-07-07

Regulatory Status

RX

2011
08 Mar
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2011-03-08

22234 / 1

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2011-03-08

Regulatory Status

RX

2011
08 Mar
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2011-03-08

22234 / 2

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2011-03-08

Regulatory Status

RX

2011
08 Mar
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2011-03-08

22234 / 3

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2011-03-08

Regulatory Status

RX

2016
23 Jun
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

4

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2016-06-23

22234 / 4

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

4

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2016-06-23

Regulatory Status

RX

2016
23 Jun
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

5

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2016-06-23

22234 / 5

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

5

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2016-06-23

Regulatory Status

RX

2017
24 Jan
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

7

Dosage Form

-

Strength

160MG/8ML (20MG/ML)

Approval Date

2017-01-24

22234 / 7

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

7

Dosage Form

-

Strength

160MG/8ML (20MG/ML)

Approval Date

2017-01-24

Regulatory Status

RX

1982
01 Jan
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

18132 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
04 Feb
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1982-02-04

18132 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1982-02-04

Regulatory Status

RX

1982
04 Feb
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1982-02-04

18132 / 3

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1982-02-04

Regulatory Status

RX

1982
09 Jul
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-07-09

18132 / 4

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

4

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-07-09

Regulatory Status

RX

1983
30 Sep
RX Application: 18826

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

80MG/100ML

Approval Date

1983-09-30

18826 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18826

Product Number

1

Dosage Form

-

Strength

80MG/100ML

Approval Date

1983-09-30

Regulatory Status

RX

1983
30 Sep
RX Application: 18826

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

160MG/100ML

Approval Date

1983-09-30

18826 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18826

Product Number

2

Dosage Form

-

Strength

160MG/100ML

Approval Date

1983-09-30

Regulatory Status

RX

1983
30 Sep
RX Application: 18826

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

320MG/100ML

Approval Date

1983-09-30

18826 / 3

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18826

Product Number

3

Dosage Form

-

Strength

320MG/100ML

Approval Date

1983-09-30

Regulatory Status

RX

1986
24 Sep
RX Application: 50609

Drug Name

ERYTHROCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-09-24

50609 / 1

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

50609

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-09-24

Regulatory Status

RX

1986
31 Oct
RX Application: 62638

Drug Name

ERYTHROCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-10-31

62638 / 1

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

62638

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-10-31

Regulatory Status

RX

1985
12 Jan
RX Application: 19115

Drug Name

FENTANYL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1985-01-12

19115 / 1

Active Ingredient

FENTANYL CITRATE

Application Number

19115

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1985-01-12

Regulatory Status

RX

2004
29 Jul
RX Application: 76303

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

76303 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76303

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2004
29 Jul
RX Application: 76303

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

76303 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76303

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

1982
28 May
RX Application: 18667

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-05-28

18667 / 1

Active Ingredient

FUROSEMIDE

Application Number

18667

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-05-28

Regulatory Status

RX

1999
28 May
RX Application: 75241

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-05-28

75241 / 1

Active Ingredient

FUROSEMIDE

Application Number

75241

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-05-28

Regulatory Status

RX

2011
25 Jul
RX Application: 78339

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

78339 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

78339

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2011
25 Jul
RX Application: 78339

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

78339 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

78339

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2010
15 Nov
RX Application: 79183

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2010-11-15

79183 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

79183

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2010-11-15

Regulatory Status

RX

2011
04 Aug
RX Application: 200795

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2011-08-04

200795 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

200795

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2011-08-04

Regulatory Status

RX

2011
04 Aug
RX Application: 200795

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2011-08-04

200795 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

200795

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2011-08-04

Regulatory Status

RX

2011
04 Aug
RX Application: 200795

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2011-08-04

200795 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

200795

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2011-08-04

Regulatory Status

RX

1983
15 Aug
RX Application: 62420

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-08-15

62420 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62420

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

RX

1983
15 Aug
RX Application: 62420

Drug Name

GENTAMICIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1983-08-15

62420 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62420

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

RX

1983
28 Apr
RX Application: 88100

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1983-04-28

88100 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

88100

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1983-04-28

Regulatory Status

RX

2009
31 Aug
RX Application: 90571

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

2009-08-31

90571 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

90571

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

2009-08-31

Regulatory Status

RX

2009
31 Aug
RX Application: 90571

Drug Name

HEPARIN SODIUM

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

2009-08-31

90571 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

90571

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

2009-08-31

Regulatory Status

RX

2009
31 Aug
RX Application: 90571

Drug Name

HEPARIN SODIUM

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2009-08-31

90571 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

90571

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2009-08-31

Regulatory Status

RX

1989
23 Jun
RX Application: 18916

Drug Name

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

Product Number

10

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

18916 / 10

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

10

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

Regulatory Status

RX

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1984
31 Jan
RX Application: 18916

Drug Name

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 6

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

RX

1989
23 Jun
RX Application: 18916

Drug Name

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

Product Number

11

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

18916 / 11

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

11

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

Regulatory Status

RX

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

4

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1984
31 Jan
RX Application: 18916

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 7

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

7

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

RX

1984
31 Jan
RX Application: 18916

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 8

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

8

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

RX

1987
04 May
RX Application: 89522

Drug Name

HEPARIN SODIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1987-05-04

89522 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

89522

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1987-05-04

Regulatory Status

RX

2008
17 Jun
RX Application: 78591

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2008-06-17

78591 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

78591

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2008-06-17

Regulatory Status

RX

2011
01 Dec
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2011-12-01

200403 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2011-12-01

Regulatory Status

RX

2011
01 Dec
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-12-01

200403 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-12-01

Regulatory Status

RX

2011
01 Dec
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-12-01

200403 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

3

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-12-01

Regulatory Status

RX

2022
13 Jun
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2022-06-13

200403 / 4

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

4

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2022-06-13

Regulatory Status

RX

2023
03 Mar
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

0.25MG/0.5ML

Approval Date

2023-03-03

200403 / 5

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

5

Dosage Form

-

Strength

0.25MG/0.5ML

Approval Date

2023-03-03

Regulatory Status

RX

2008
27 Feb
RX Application: 77915

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

77915 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77915

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

2008
27 Feb
RX Application: 77915

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

77915 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77915

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

2008
27 Feb
RX Application: 78796

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2008-02-27

78796 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

78796

Product Number

1

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

1996
27 Jun
RX Application: 74549

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1996-06-27

74549 / 1

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

74549

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1996-06-27

Regulatory Status

RX

1996
27 Jun
RX Application: 74549

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1996-06-27

74549 / 2

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

74549

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1996-06-27

Regulatory Status

RX

1997
05 Jun
RX Application: 74802

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1997-06-05

74802 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74802

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1997-06-05

Regulatory Status

RX

1997
05 Jun
RX Application: 74802

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-06-05

74802 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74802

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-06-05

Regulatory Status

RX

1999
29 Nov
RX Application: 75239

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

75239 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

75239

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

Regulatory Status

RX

1999
29 Nov
RX Application: 75240

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

75240 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

75240

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

Regulatory Status

RX

2012
06 Apr
RX Application: 202869

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2012-04-06

202869 / 1

Active Ingredient

LEVETIRACETAM

Application Number

202869

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2012-04-06

Regulatory Status

RX

2015
03 Sep
RX Application: 78579

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2015-09-03

78579 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

78579

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2015-09-03

Regulatory Status

RX

2015
03 Sep
RX Application: 78579

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2015-09-03

78579 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

78579

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2015-09-03

Regulatory Status

RX

2015
03 Sep
RX Application: 78579

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2015-09-03

78579 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

78579

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2015-09-03

Regulatory Status

RX

1982
01 Jan
RX Application: 7513

Drug Name

LEVOPHED

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1982-01-01

7513 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

7513

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

RX

1995
23 Jun
RX Application: 40078

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-06-23

40078 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40078

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-06-23

Regulatory Status

RX

1984
17 May
RX Application: 88294

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-05-17

88294 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88294

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-05-17

Regulatory Status

RX

1984
17 May
RX Application: 88328

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-05-17

88328 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88328

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-05-17

Regulatory Status

RX

1984
17 May
RX Application: 88329

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-05-17

88329 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88329

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-05-17

Regulatory Status

RX

1982
01 Jan
RX Application: 83914

Drug Name

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

83914 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83914

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

Regulatory Status

RX

1985
13 Sep
RX Application: 88571

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1985-09-13

88571 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

88571

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1985-09-13

Regulatory Status

RX

1988
21 Jun
RX Application: 89635

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;0.5%

Approval Date

1988-06-21

89635 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89635

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;0.5%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89644

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;1%

Approval Date

1988-06-21

89644 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89644

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;1%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89645

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1988-06-21

89645 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89645

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89646

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2%

Approval Date

1988-06-21

89646 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89646

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89651

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1988-06-21

89651 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89651

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1988-06-21

Regulatory Status

RX

1984
31 Jul
RX Application: 88299

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-07-31

88299 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88299

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-07-31

Regulatory Status

RX

1984
31 Jul
RX Application: 88325

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-07-31

88325 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88325

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-07-31

Regulatory Status

RX

1984
31 Jul
RX Application: 88327

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-07-31

88327 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88327

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-07-31

Regulatory Status

RX

1982
01 Jan
RX Application: 80408

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80408 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

80408

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 80408

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

80408 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

80408

Product Number

2

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

Regulatory Status

RX

1984
17 May
RX Application: 88295

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-05-17

88295 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88295

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-05-17

Regulatory Status

RX

1998
28 Sep
RX Application: 40302

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1998-09-28

40302 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40302

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1998-09-28

Regulatory Status

RX

1998
28 Sep
RX Application: 40302

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1998-09-28

40302 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40302

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1998-09-28

Regulatory Status

RX

2015
18 Jun
RX Application: 206473

Drug Name

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-06-18

206473 / 1

Active Ingredient

LINEZOLID

Application Number

206473

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-06-18

Regulatory Status

RX

1994
12 Apr
RX Application: 74243

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-04-12

74243 / 1

Active Ingredient

LORAZEPAM

Application Number

74243

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-04-12

Regulatory Status

RX

1994
12 Apr
RX Application: 74243

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-04-12

74243 / 2

Active Ingredient

LORAZEPAM

Application Number

74243

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-04-12

Regulatory Status

RX

2000
25 Apr
RX Application: 75151

Drug Name

MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

5GM/10ML (500MG/ML)

Approval Date

2000-04-25

75151 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

75151

Product Number

1

Dosage Form

-

Strength

5GM/10ML (500MG/ML)

Approval Date

2000-04-25

Regulatory Status

RX

2015
14 May
RX Application: 202411

Drug Name

MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

10GM/20ML (500MG/ML)

Approval Date

2015-05-14

202411 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

202411

Product Number

1

Dosage Form

-

Strength

10GM/20ML (500MG/ML)

Approval Date

2015-05-14

Regulatory Status

RX

1995
11 Jul
RX Application: 20488

Drug Name

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

1995-07-11

20488 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

20488

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

1995-07-11

Regulatory Status

RX

1995
11 Jul
RX Application: 20488

Drug Name

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2GM/100ML

Approval Date

1995-07-11

20488 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

20488

Product Number

2

Dosage Form

-

Strength

2GM/100ML

Approval Date

1995-07-11

Regulatory Status

RX

1994
24 Jun
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

1994-06-24

20309 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

1

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

1994-06-24

Regulatory Status

RX

1994
24 Jun
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

1994-06-24

20309 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

1994-06-24

Regulatory Status

RX

2007
26 Jan
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2007-01-26

20309 / 3

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

3

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2007-01-26

Regulatory Status

RX

1995
18 Jan
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

20GM/500ML (40MG/ML)

Approval Date

1995-01-18

20309 / 4

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

4

Dosage Form

-

Strength

20GM/500ML (40MG/ML)

Approval Date

1995-01-18

Regulatory Status

RX

1995
18 Jan
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

40GM/1000ML (40MG/ML)

Approval Date

1995-01-18

20309 / 5

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

5

Dosage Form

-

Strength

40GM/1000ML (40MG/ML)

Approval Date

1995-01-18

Regulatory Status

RX

1986
26 Jun
RX Application: 18962

Drug Name

MANGANESE CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG MANGANESE/ML

Approval Date

1986-06-26

18962 / 1

Active Ingredient

MANGANESE CHLORIDE

Application Number

18962

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG MANGANESE/ML

Approval Date

1986-06-26

Regulatory Status

RX

1994
25 Aug
RX Application: 16269

Drug Name

MANNITOL 25%

Product Number

6

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1994-08-25

16269 / 6

Active Ingredient

MANNITOL

Application Number

16269

Product Number

6

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1994-08-25

Regulatory Status

RX

1984
04 May
RX Application: 18692

Drug Name

MARCAINE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1984-05-04

18692 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18692

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1984-05-04

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

16964 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

16964 / 6

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

6

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

5

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

16964 / 5

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

5

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

9

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

16964 / 9

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

9

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

12

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

16964 / 12

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

12

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

Product Number

4

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 4

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

4

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

Product Number

8

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 8

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

8

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

Product Number

7

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 7

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

7

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

Product Number

10

Dosage Form

-

Strength

0.75%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 10

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

10

Dosage Form

-

Strength

0.75%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

Product Number

13

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 13

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

13

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2004
15 Dec
RX Application: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

10

Dosage Form

-

Strength

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

Approval Date

2004-12-15

11719 / 10

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

10

Dosage Form

-

Strength

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

Approval Date

2004-12-15

Regulatory Status

RX

2005
13 Apr
RX Application: 11719

Drug Name

METHOTREXATE SODIUM PRESERVATIVE FREE

Product Number

12

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2005-04-13

11719 / 12

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

12

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2005-04-13

Regulatory Status

RX

1991
17 Jan
RX Application: 73118

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-01-17

73118 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

73118

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-01-17

Regulatory Status

RX

2008
29 Apr
RX Application: 78085

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2008-04-29

78085 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

78085

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2008-04-29

Regulatory Status

RX

1983
18 Nov
RX Application: 18890

Drug Name

METRONIDAZOLE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

500MG/100ML

Approval Date

1983-11-18

18890 / 2

Active Ingredient

METRONIDAZOLE

Application Number

18890

Product Number

2

Dosage Form

-

Strength

500MG/100ML

Approval Date

1983-11-18

Regulatory Status

RX

2000
20 Jun
RX Application: 75293

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75293 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75293

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75293

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75293 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75293

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2002
22 Jul
RX Application: 75857

Drug Name

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-07-22

75857 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75857

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-07-22

Regulatory Status

RX

2002
22 Jul
RX Application: 75857

Drug Name

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2002-07-22

75857 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75857

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2002-07-22

Regulatory Status

RX

2014
03 Sep
RX Application: 203280

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2014-09-03

203280 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

203280

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2014-09-03

Regulatory Status

RX

2006
11 Apr
RX Application: 76871

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2006-04-11

76871 / 1

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76871

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: 76871

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2006-04-11

76871 / 2

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76871

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: 76871

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2006-04-11

76871 / 3

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76871

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2006-04-11

Regulatory Status

RX

1992
30 Sep
RX Application: 73509

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1992-09-30

73509 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

73509

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1992-09-30

Regulatory Status

RX

1992
30 Sep
RX Application: 73510

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1992-09-30

73510 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

73510

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1992-09-30

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-11-14

202515 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-11-14

202515 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

8MG/ML

Approval Date

2011-11-14

202515 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

3

Dosage Form

-

Strength

8MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2011-11-14

202515 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2021
29 Apr
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

6

Dosage Form

-

Strength

50MG/ML

Approval Date

2021-04-29

202515 / 6

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

6

Dosage Form

-

Strength

50MG/ML

Approval Date

2021-04-29

Regulatory Status

RX

1989
03 Feb
RX Application: 70914

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

1989-02-03

70914 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70914

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1989
03 Feb
RX Application: 70915

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

1989-02-03

70915 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70915

Product Number

1

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1989
03 Feb
RX Application: 70916

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

1989-02-03

70916 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70916

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1989
03 Feb
RX Application: 70918

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/10ML (20MG/ML)

Approval Date

1989-02-03

70918 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70918

Product Number

1

Dosage Form

-

Strength

200MG/10ML (20MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1986
24 Sep
RX Application: 70172

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

70172 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70172

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

Regulatory Status

RX

1987
07 Jan
RX Application: 70256

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

70256 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70256

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

Regulatory Status

RX

1987
07 Jan
RX Application: 70257

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

70257 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70257

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

Regulatory Status

RX

1991
11 Oct
RX Application: 20122

Drug Name

NIPENT

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1991-10-11

20122 / 1

Active Ingredient

PENTOSTATIN

Application Number

20122

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1991-10-11

Regulatory Status

RX

2006
26 Dec
RX Application: 77473

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77473 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77473

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2006
26 Dec
RX Application: 77548

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77548 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77548

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2009
07 Aug
RX Application: 78813

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

78813 / 1

Active Ingredient

OXALIPLATIN

Application Number

78813

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

RX

2009
07 Aug
RX Application: 78813

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

78813 / 2

Active Ingredient

OXALIPLATIN

Application Number

78813

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

RX

2002
08 May
RX Application: 76131

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-05-08

76131 / 1

Active Ingredient

PACLITAXEL

Application Number

76131

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-05-08

Regulatory Status

RX

2018
19 Sep
RX Application: 207005

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

207005 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

207005

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2018-09-19

Regulatory Status

RX

2002
27 Jun
RX Application: 75841

Drug Name

PAMIDRONATE DISODIUM

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-06-27

75841 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75841

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-06-27

Regulatory Status

RX

2002
27 Jun
RX Application: 75841

Drug Name

PAMIDRONATE DISODIUM

Product Number

2

Dosage Form

-

Strength

60MG/10ML (6MG/ML)

Approval Date

2002-06-27

75841 / 2

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75841

Product Number

2

Dosage Form

-

Strength

60MG/10ML (6MG/ML)

Approval Date

2002-06-27

Regulatory Status

RX

2002
27 Jun
RX Application: 75841

Drug Name

PAMIDRONATE DISODIUM

Product Number

3

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-06-27

75841 / 3

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75841

Product Number

3

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-06-27

Regulatory Status

RX

2022
22 Jun
RX Application: 214218

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

214218 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

214218

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

Regulatory Status

RX

2022
22 Jun
RX Application: 214218

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

214218 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

214218

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

Regulatory Status

RX

2022
22 Jun
RX Application: 214218

Drug Name

PEMETREXED DISODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

214218 / 3

Active Ingredient

PEMETREXED DISODIUM

Application Number

214218

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

Regulatory Status

RX

1982
26 Feb
RX Application: 18608

Drug Name

PLEGISOL IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-02-26

18608 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18608

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-02-26

Regulatory Status

RX

1984
20 Jul
RX Application: 18896

Drug Name

POTASSIUM ACETATE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1984-07-20

18896 / 1

Active Ingredient

POTASSIUM ACETATE

Application Number

18896

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1984-07-20

Regulatory Status

RX

1982
01 Jan
RX Application: 80205

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

80205 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

80205

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

RX

2025
11 Sep
RX Application: 217459

Drug Name

POTASSIUM PHOSPHATES

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2025-09-11

217459 / 1

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

217459

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2025-09-11

Regulatory Status

RX

1999
17 Dec
RX Application: 21038

Drug Name

PRECEDEX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1999-12-17

21038 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1999-12-17

Regulatory Status

RX

2013
13 Mar
RX Application: 21038

Drug Name

PRECEDEX

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-03-13

21038 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-03-13

Regulatory Status

RX

2013
13 Mar
RX Application: 21038

Drug Name

PRECEDEX

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-03-13

21038 / 3

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-03-13

Regulatory Status

RX

2014
14 Nov
RX Application: 21038

Drug Name

PRECEDEX

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2014-11-14

21038 / 4

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2014-11-14

Regulatory Status

RX

2020
31 Jan
RX Application: 21038

Drug Name

PRECEDEX

Product Number

5

Dosage Form

-

Strength

EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

Approval Date

2020-01-31

21038 / 5

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

5

Dosage Form

-

Strength

EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

Approval Date

2020-01-31

Regulatory Status

RX

1986
12 Feb
RX Application: 89069

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1986-02-12

89069 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89069

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1986-02-12

Regulatory Status

RX

2006
17 Mar
RX Application: 77908

Drug Name

PROPOFOL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2006-03-17

77908 / 1

Active Ingredient

PROPOFOL

Application Number

77908

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2006-03-17

Regulatory Status

RX

1982
01 Jan
RX Application: 8845

Drug Name

QUELICIN

Product Number

6

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

8845 / 6

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8845

Product Number

6

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2022
31 Aug
RX Application: 214349

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-08-31

214349 / 1

Active Ingredient

REGADENOSON

Application Number

214349

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-08-31

Regulatory Status

RX

2008
26 Nov
RX Application: 78519

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-11-26

78519 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78519

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-11-26

Regulatory Status

RX

2008
26 Nov
RX Application: 78519

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-11-26

78519 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78519

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-11-26

Regulatory Status

RX

1983
04 May
RX Application: 18893

Drug Name

SODIUM ACETATE

Product Number

1

Dosage Form

-

Strength

40MEQ/20ML (2MEQ/ML)

Approval Date

1983-05-04

18893 / 1

Active Ingredient

SODIUM ACETATE

Application Number

18893

Product Number

1

Dosage Form

-

Strength

40MEQ/20ML (2MEQ/ML)

Approval Date

1983-05-04

Regulatory Status

RX

2014
02 Sep
RX Application: 18893

Drug Name

SODIUM ACETATE

Product Number

2

Dosage Form

-

Strength

100MEQ/50ML (2MEQ/ML)

Approval Date

2014-09-02

18893 / 2

Active Ingredient

SODIUM ACETATE

Application Number

18893

Product Number

2

Dosage Form

-

Strength

100MEQ/50ML (2MEQ/ML)

Approval Date

2014-09-02

Regulatory Status

RX

2014
02 Sep
RX Application: 18893

Drug Name

SODIUM ACETATE

Product Number

3

Dosage Form

-

Strength

200MEQ/100ML (2MEQ/ML)

Approval Date

2014-09-02

18893 / 3

Active Ingredient

SODIUM ACETATE

Application Number

18893

Product Number

3

Dosage Form

-

Strength

200MEQ/100ML (2MEQ/ML)

Approval Date

2014-09-02

Regulatory Status

RX

2017
26 Sep
RX Application: 202432

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-09-26

202432 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202432

Product Number

1

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-09-26

Regulatory Status

RX

2017
06 Mar
RX Application: 202494

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

44.6MEQ/50ML (0.9MEQ/ML)

Approval Date

2017-03-06

202494 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202494

Product Number

1

Dosage Form

-

Strength

44.6MEQ/50ML (0.9MEQ/ML)

Approval Date

2017-03-06

Regulatory Status

RX

2017
06 Mar
RX Application: 202494

Drug Name

SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-03-06

202494 / 2

Active Ingredient

SODIUM BICARBONATE

Application Number

202494

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-03-06

Regulatory Status

RX

2017
06 Mar
RX Application: 202495

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

10MEQ/10ML (1MEQ/ML)

Approval Date

2017-03-06

202495 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202495

Product Number

1

Dosage Form

-

Strength

10MEQ/10ML (1MEQ/ML)

Approval Date

2017-03-06

Regulatory Status

RX

2017
07 Mar
RX Application: 202679

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

5MEQ/10ML (0.5MEQ/ML)

Approval Date

2017-03-07

202679 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202679

Product Number

1

Dosage Form

-

Strength

5MEQ/10ML (0.5MEQ/ML)

Approval Date

2017-03-07

Regulatory Status

RX

2016
04 Mar
RX Application: 202981

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Approval Date

2016-03-04

202981 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202981

Product Number

1

Dosage Form

-

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Approval Date

2016-03-04

Regulatory Status

RX

1988
08 Jun
RX Application: 19759

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1988-06-08

19759 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19759

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1988-06-08

Regulatory Status

RX

1982
29 Oct
RX Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

18803 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

18803 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1982-10-29

18803 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

3

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1985
15 Jul
RX Application: 19465

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-07-15

19465 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19465

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-07-15

Regulatory Status

RX

1985
15 Jul
RX Application: 19465

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1985-07-15

19465 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

19465

Product Number

2

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1985-07-15

Regulatory Status

RX

1985
17 Sep
RX Application: 19480

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-09-17

19480 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19480

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-09-17

Regulatory Status

RX

1984
20 Jul
RX Application: 18897

Drug Name

SODIUM CHLORIDE 14.6%

Product Number

2

Dosage Form

-

Strength

100MEQ/40ML (2.5MEQ/ML)

Approval Date

1984-07-20

18897 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

18897

Product Number

2

Dosage Form

-

Strength

100MEQ/40ML (2.5MEQ/ML)

Approval Date

1984-07-20

Regulatory Status

RX

2020
18 Jun
RX Application: 18897

Drug Name

SODIUM CHLORIDE 23.4%

Product Number

3

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2020-06-18

18897 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

18897

Product Number

3

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2020-06-18

Regulatory Status

RX

1983
10 May
RX Application: 18892

Drug Name

SODIUM PHOSPHATES IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-05-10

18892 / 1

Active Ingredient

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

Application Number

18892

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-05-10

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

2

Dosage Form

-

Strength

100% (10ML)

Approval Date

1982-10-27

18801 / 2

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

2

Dosage Form

-

Strength

100% (10ML)

Approval Date

1982-10-27

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

3

Dosage Form

-

Strength

100% (20ML)

Approval Date

1982-10-27

18801 / 3

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

3

Dosage Form

-

Strength

100% (20ML)

Approval Date

1982-10-27

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

4

Dosage Form

-

Strength

100% (50ML)

Approval Date

1982-10-27

18801 / 4

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

4

Dosage Form

-

Strength

100% (50ML)

Approval Date

1982-10-27

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

5

Dosage Form

-

Strength

100% (100ML)

Approval Date

1982-10-27

18801 / 5

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

5

Dosage Form

-

Strength

100% (100ML)

Approval Date

1982-10-27

Regulatory Status

RX

2023
02 May
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

6

Dosage Form

-

Strength

100% (5.2ML)

Approval Date

2023-05-02

18801 / 6

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

6

Dosage Form

-

Strength

100% (5.2ML)

Approval Date

2023-05-02

Regulatory Status

RX

1996
11 Dec
RX Application: 74534

Drug Name

SUFENTANIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1996-12-11

74534 / 1

Active Ingredient

SUFENTANIL CITRATE

Application Number

74534

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1996-12-11

Regulatory Status

RX

1986
06 Mar
RX Application: 62662

Drug Name

TAZICEF

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-03-06

62662 / 2

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-03-06

Regulatory Status

RX

1986
06 Mar
RX Application: 62662

Drug Name

TAZICEF

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1986-03-06

62662 / 3

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1986-03-06

Regulatory Status

RX

1986
06 Mar
RX Application: 62662

Drug Name

TAZICEF

Product Number

4

Dosage Form

-

Strength

6GM/VIAL

Approval Date

1986-03-06

62662 / 4

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

4

Dosage Form

-

Strength

6GM/VIAL

Approval Date

1986-03-06

Regulatory Status

RX

1993
31 Oct
RX Application: 64032

Drug Name

TAZICEF

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1993-10-31

64032 / 1

Active Ingredient

CEFTAZIDIME

Application Number

64032

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1993-10-31

Regulatory Status

RX

1993
31 Oct
RX Application: 64032

Drug Name

TAZICEF

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1993-10-31

64032 / 2

Active Ingredient

CEFTAZIDIME

Application Number

64032

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1993-10-31

Regulatory Status

RX

1982
01 Jan
RX Application: 13025

Drug Name

THAM

Product Number

2

Dosage Form

-

Strength

18GM/500ML (3.6GM/100ML)

Approval Date

1982-01-01

13025 / 2

Active Ingredient

TROMETHAMINE

Application Number

13025

Product Number

2

Dosage Form

-

Strength

18GM/500ML (3.6GM/100ML)

Approval Date

1982-01-01

Regulatory Status

RX

1991
30 Apr
RX Application: 63111

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-04-30

63111 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63111

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-04-30

Regulatory Status

RX

2011
02 Feb
RX Application: 200582

Drug Name

TOPOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-02-02

200582 / 1

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

200582

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-02-02

Regulatory Status

RX

1984
20 Jul
RX Application: 18895

Drug Name

TPN ELECTROLYTES IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML

Approval Date

1984-07-20

18895 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

18895

Product Number

1

Dosage Form

-

Strength

16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML

Approval Date

1984-07-20

Regulatory Status

RX

1988
04 Aug
RX Application: 62911

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-08-04

62911 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62911

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-08-04

Regulatory Status

RX

1988
04 Aug
RX Application: 62912

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-08-04

62912 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62912

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-08-04

Regulatory Status

RX

2009
07 Jan
RX Application: 62912

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-01-07

62912 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62912

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-01-07

Regulatory Status

RX

2020
10 Jul
RX Application: 62912

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2020-07-10

62912 / 3

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62912

Product Number

3

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2020-07-10

Regulatory Status

RX

1992
29 Oct
RX Application: 62931

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1992-10-29

62931 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62931

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1992-10-29

Regulatory Status

RX

1992
29 Oct
RX Application: 62933

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1992-10-29

62933 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62933

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1992-10-29

Regulatory Status

RX

2009
27 May
RX Application: 62933

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-05-27

62933 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62933

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-05-27

Regulatory Status

RX

1990
21 Dec
RX Application: 63076

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1990-12-21

63076 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

63076

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1990-12-21

Regulatory Status

RX

2020
14 Sep
RX Application: 63076

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2020-09-14

63076 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

63076

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2020-09-14

Regulatory Status

RX

1999
21 Oct
RX Application: 75164

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1999-10-21

75164 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

75164

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1999-10-21

Regulatory Status

RX

1999
21 Oct
RX Application: 75164

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-10-21

75164 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

75164

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-10-21

Regulatory Status

RX

1987
06 May
RX Application: 70737

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

70737 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70737

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

Regulatory Status

RX

1987
06 May
RX Application: 70737

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

1987-05-06

70737 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70737

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

1987-05-06

Regulatory Status

RX

1987
06 May
RX Application: 70738

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

70738 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70738

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

Regulatory Status

RX

1988
19 Apr
RX Application: 71484

Drug Name

VINCRISTINE SULFATE PFS

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-04-19

71484 / 1

Active Ingredient

VINCRISTINE SULFATE

Application Number

71484

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-04-19

Regulatory Status

RX

1983
25 Jul
RX Application: 87954

Drug Name

VITAMIN K1

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1983-07-25

87954 / 1

Active Ingredient

PHYTONADIONE

Application Number

87954

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1983-07-25

Regulatory Status

RX

1983
25 Jul
RX Application: 87955

Drug Name

VITAMIN K1

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1983-07-25

87955 / 1

Active Ingredient

PHYTONADIONE

Application Number

87955

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1983-07-25

Regulatory Status

RX

1986
26 Jun
RX Application: 18959

Drug Name

ZINC CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 1MG ZINC/ML

Approval Date

1986-06-26

18959 / 1

Active Ingredient

ZINC CHLORIDE

Application Number

18959

Product Number

1

Dosage Form

-

Strength

EQ 1MG ZINC/ML

Approval Date

1986-06-26

Regulatory Status

RX

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Drug Status Breakdown
288 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

ACETYLCYSTEINE

Application Number

73664

Product Number

1

Active Ingredient

ACETYLCYSTEINE

Dosage Form

-

Strength

10%

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Searchable pharmaceutical data

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