Baxter Healthcare Corporation
FDA Approved Drugs

Baxter Healthcare Corporation

FDA Approved Drugs Database

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

RX Discontinued Unclassified
  • Total Records 497
  • Latest Approval Date Aug 11, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
497
View
Unclassified
9
View
Discontinued
212
View
RX
276
View
Company Overview

Company

Baxter Healthcare Corporation

Country

U.S.A

Website

Visit Website

Email

onebaxter@baxter.com

Social Profiles

Company Snapshot

Baxter Healthcare Corporation

One Baxter Parkway Deerfield, IL 60015-4625

U.S.A

www.baxter.com/ onebaxter@baxter.com View on Map
FDA Approved Drug Records ( 497 records )
2021
17 Sep
RX Application: 214331

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2021-09-17

214331 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

214331

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2021-09-17

Regulatory Status

RX

2025
21 May
RX Application: 214331

Drug Name

ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG/65ML (10MG/ML)

Approval Date

2025-05-21

214331 / 2

Active Ingredient

ACETAMINOPHEN

Application Number

214331

Product Number

2

Dosage Form

-

Strength

650MG/65ML (10MG/ML)

Approval Date

2025-05-21

Regulatory Status

RX

1982
19 Feb
RX Application: 18523

Drug Name

ACETIC ACID 0.25% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

250MG/100ML

Approval Date

1982-02-19

18523 / 1

Active Ingredient

ACETIC ACID, GLACIAL

Application Number

18523

Product Number

1

Dosage Form

-

Strength

250MG/100ML

Approval Date

1982-02-19

Regulatory Status

RX

1982
01 Jan
RX Application: 17865

Drug Name

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1.5GM/100ML

Approval Date

1982-01-01

17865 / 1

Active Ingredient

GLYCINE

Application Number

17865

Product Number

1

Dosage Form

-

Strength

1.5GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
29 Oct
Discontinued Application: 18590

Drug Name

AMINOCAPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1982-10-29

18590 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

18590

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1982-10-29

Regulatory Status

Discontinued

2000
10 May
Discontinued Application: 75542

Drug Name

AMRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-05-10

75542 / 1

Active Ingredient

INAMRINONE LACTATE

Application Number

75542

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-05-10

Regulatory Status

Discontinued

1983
08 Jun
Discontinued Application: 50566

Drug Name

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-06-08

50566 / 3

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50566

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-06-08

Regulatory Status

Discontinued

1983
08 Jun
Discontinued Application: 50566

Drug Name

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1983-06-08

50566 / 4

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50566

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1983-06-08

Regulatory Status

Discontinued

1991
28 Mar
Discontinued Application: 63002

Drug Name

ANCEF IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-03-28

63002 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63002

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-03-28

Regulatory Status

Discontinued

1991
28 Mar
Discontinued Application: 63002

Drug Name

ANCEF IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1991-03-28

63002 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

63002

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1991-03-28

Regulatory Status

Discontinued

1983
08 Jun
Discontinued Application: 50566

Drug Name

ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-06-08

50566 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50566

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-06-08

Regulatory Status

Discontinued

1983
08 Jun
Discontinued Application: 50566

Drug Name

ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1983-06-08

50566 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

50566

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1983-06-08

Regulatory Status

Discontinued

-
Unclassified Application: 22359

Drug Name

ARGATROBAN

Product Number

1

Dosage Form

-

Strength

250MG/250ML

Approval Date

-

22359 / 1

Active Ingredient

ARGATROBAN

Application Number

22359

Product Number

1

Dosage Form

-

Strength

250MG/250ML

Approval Date

-

Regulatory Status

Unclassified

1997
23 Jan
Discontinued Application: 74753

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-01-23

74753 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74753

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-01-23

Regulatory Status

Discontinued

1997
30 Sep
Discontinued Application: 74824

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-09-30

74824 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74824

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-09-30

Regulatory Status

Discontinued

1997
23 Jan
Discontinued Application: 74768

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-01-23

74768 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74768

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-01-23

Regulatory Status

Discontinued

1997
30 Sep
Discontinued Application: 74825

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-09-30

74825 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74825

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-09-30

Regulatory Status

Discontinued

1989
26 Oct
Discontinued Application: 50640

Drug Name

BACTOCILL IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1989-10-26

50640 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

50640

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1989-10-26

Regulatory Status

Discontinued

1989
26 Oct
RX Application: 50640

Drug Name

BACTOCILL IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1989-10-26

50640 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

50640

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1989-10-26

Regulatory Status

RX

2022
15 Dec
RX Application: 216078

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

2022-12-15

216078 / 1

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

216078

Product Number

1

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

2022-12-15

Regulatory Status

RX

2017
21 Dec
Discontinued Application: 208374

Drug Name

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG/50ML (5MG/ML)

Approval Date

2017-12-21

208374 / 1

Active Ingredient

BIVALIRUDIN

Application Number

208374

Product Number

1

Dosage Form

-

Strength

250MG/50ML (5MG/ML)

Approval Date

2017-12-21

Regulatory Status

Discontinued

2017
21 Dec
Discontinued Application: 208374

Drug Name

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2017-12-21

208374 / 2

Active Ingredient

BIVALIRUDIN

Application Number

208374

Product Number

2

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2017-12-21

Regulatory Status

Discontinued

2022
02 May
Discontinued Application: 213823

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

213823 / 1

Active Ingredient

BORTEZOMIB

Application Number

213823

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

Discontinued

1984
28 Sep
Discontinued Application: 18678

Drug Name

BRANCHAMIN 4%

Product Number

1

Dosage Form

-

Strength

4% (4GM/100ML)

Approval Date

1984-09-28

18678 / 1

Active Ingredient

AMINO ACIDS

Application Number

18678

Product Number

1

Dosage Form

-

Strength

4% (4GM/100ML)

Approval Date

1984-09-28

Regulatory Status

Discontinued

1984
28 Sep
Discontinued Application: 18684

Drug Name

BRANCHAMIN 4% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4% (4GM/100ML)

Approval Date

1984-09-28

18684 / 1

Active Ingredient

AMINO ACIDS

Application Number

18684

Product Number

1

Dosage Form

-

Strength

4% (4GM/100ML)

Approval Date

1984-09-28

Regulatory Status

Discontinued

1989
12 Apr
Discontinued Application: 19837

Drug Name

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

400MG/100ML

Approval Date

1989-04-12

19837 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19837

Product Number

1

Dosage Form

-

Strength

400MG/100ML

Approval Date

1989-04-12

Regulatory Status

Discontinued

1989
12 Apr
Discontinued Application: 19837

Drug Name

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1989-04-12

19837 / 2

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19837

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1989-04-12

Regulatory Status

Discontinued

-
Unclassified Application: 19386

Drug Name

BREVIBLOC

Product Number

2

Dosage Form

-

Strength

250MG/ML

Approval Date

-

19386 / 2

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

19386

Product Number

2

Dosage Form

-

Strength

250MG/ML

Approval Date

-

Regulatory Status

Unclassified

1988
15 Aug
Discontinued Application: 19386

Drug Name

BREVIBLOC

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

1988-08-15

19386 / 3

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

19386

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

1988-08-15

Regulatory Status

Discontinued

2003
25 Feb
RX Application: 19386

Drug Name

BREVIBLOC

Product Number

6

Dosage Form

-

Strength

10MG/ML

Approval Date

2003-02-25

19386 / 6

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

19386

Product Number

6

Dosage Form

-

Strength

10MG/ML

Approval Date

2003-02-25

Regulatory Status

RX

2003
28 May
Discontinued Application: 19386

Drug Name

BREVIBLOC

Product Number

7

Dosage Form

-

Strength

20MG/ML

Approval Date

2003-05-28

19386 / 7

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

19386

Product Number

7

Dosage Form

-

Strength

20MG/ML

Approval Date

2003-05-28

Regulatory Status

Discontinued

2003
27 Jan
RX Application: 19386

Drug Name

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

2GM/100ML

Approval Date

2003-01-27

19386 / 5

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

19386

Product Number

5

Dosage Form

-

Strength

2GM/100ML

Approval Date

2003-01-27

Regulatory Status

RX

2001
16 Feb
RX Application: 19386

Drug Name

BREVIBLOC IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

1GM/100ML

Approval Date

2001-02-16

19386 / 4

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

19386

Product Number

4

Dosage Form

-

Strength

1GM/100ML

Approval Date

2001-02-16

Regulatory Status

RX

2016
25 Jul
Discontinued Application: 207266

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2016-07-25

207266 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

207266

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2016-07-25

Regulatory Status

Discontinued

2001
23 Oct
Discontinued Application: 75697

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2001-10-23

75697 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75697

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2001-10-23

Regulatory Status

Discontinued

2001
23 Oct
Discontinued Application: 75695

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2001-10-23

75695 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75695

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2001-10-23

Regulatory Status

Discontinued

2001
23 Oct
Discontinued Application: 75695

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2001-10-23

75695 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75695

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2001-10-23

Regulatory Status

Discontinued

2000
21 Apr
RX Application: 75323

Drug Name

CARDIOPLEGIC IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2000-04-21

75323 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

75323

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2000-04-21

Regulatory Status

RX

2015
07 Aug
RX Application: 207131

Drug Name

CEFAZOLIN IN DEXTROSE

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/100ML (EQ 20MG BASE/ML)

Approval Date

2015-08-07

207131 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

207131

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/100ML (EQ 20MG BASE/ML)

Approval Date

2015-08-07

Regulatory Status

RX

2021
01 Feb
RX Application: 207131

Drug Name

CEFAZOLIN IN DEXTROSE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/50ML (EQ 20MG BASE/ML)

Approval Date

2021-02-01

207131 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

207131

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/50ML (EQ 20MG BASE/ML)

Approval Date

2021-02-01

Regulatory Status

RX

2024
31 May
RX Application: 207131

Drug Name

CEFAZOLIN IN DEXTROSE

Product Number

3

Dosage Form

-

Strength

EQ 3GM BASE/150ML (EQ 20MG BASE/ML)

Approval Date

2024-05-31

207131 / 3

Active Ingredient

CEFAZOLIN SODIUM

Application Number

207131

Product Number

3

Dosage Form

-

Strength

EQ 3GM BASE/150ML (EQ 20MG BASE/ML)

Approval Date

2024-05-31

Regulatory Status

RX

2008
05 Aug
RX Application: 50817

Drug Name

CEFEPIME IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/50ML (EQ 20MG BASE/ML)

Approval Date

2008-08-05

50817 / 1

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

50817

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/50ML (EQ 20MG BASE/ML)

Approval Date

2008-08-05

Regulatory Status

RX

2008
05 Aug
RX Application: 50817

Drug Name

CEFEPIME IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/100ML (EQ 20MG BASE/ML)

Approval Date

2008-08-05

50817 / 2

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

50817

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/100ML (EQ 20MG BASE/ML)

Approval Date

2008-08-05

Regulatory Status

RX

1993
29 Apr
Discontinued Application: 63221

Drug Name

CEFTAZIDIME SODIUM IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1993-04-29

63221 / 1

Active Ingredient

CEFTAZIDIME SODIUM

Application Number

63221

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1993-04-29

Regulatory Status

Discontinued

1993
29 Apr
Discontinued Application: 63221

Drug Name

CEFTAZIDIME SODIUM IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1993-04-29

63221 / 2

Active Ingredient

CEFTAZIDIME SODIUM

Application Number

63221

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1993-04-29

Regulatory Status

Discontinued

1993
29 Apr
Discontinued Application: 63221

Drug Name

CEFTAZIDIME SODIUM IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1993-04-29

63221 / 3

Active Ingredient

CEFTAZIDIME SODIUM

Application Number

63221

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1993-04-29

Regulatory Status

Discontinued

2005
23 Aug
RX Application: 65224

Drug Name

CEFTRIAXONE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2005-08-23

65224 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65224

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

2005-08-23

Regulatory Status

RX

2005
23 Aug
RX Application: 65224

Drug Name

CEFTRIAXONE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2005-08-23

65224 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65224

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2005-08-23

Regulatory Status

RX

1984
31 Jan
Discontinued Application: 62422

Drug Name

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1984-01-31

62422 / 3

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62422

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 62422

Drug Name

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1984-01-31

62422 / 4

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62422

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1991
16 Jul
Discontinued Application: 62422

Drug Name

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1991-07-16

62422 / 5

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62422

Product Number

5

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1991-07-16

Regulatory Status

Discontinued

1991
16 Jul
Discontinued Application: 62422

Drug Name

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-07-16

62422 / 6

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62422

Product Number

6

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-07-16

Regulatory Status

Discontinued

1987
05 Mar
Discontinued Application: 62730

Drug Name

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1987-03-05

62730 / 1

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62730

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1987-03-05

Regulatory Status

Discontinued

1987
05 Mar
Discontinued Application: 62730

Drug Name

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1987-03-05

62730 / 2

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62730

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1987-03-05

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 62422

Drug Name

CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1984-01-31

62422 / 1

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62422

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 62422

Drug Name

CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1984-01-31

62422 / 2

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62422

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

2008
29 Apr
Discontinued Application: 78062

Drug Name

CIPROFLOXACIN

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2008-04-29

78062 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

78062

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2008-04-29

Regulatory Status

Discontinued

2008
29 Apr
Discontinued Application: 78062

Drug Name

CIPROFLOXACIN

Product Number

2

Dosage Form

-

Strength

400MG/40ML (10MG/ML)

Approval Date

2008-04-29

78062 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

78062

Product Number

2

Dosage Form

-

Strength

400MG/40ML (10MG/ML)

Approval Date

2008-04-29

Regulatory Status

Discontinued

2008
18 Mar
Discontinued Application: 77888

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

77888 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

77888

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

Regulatory Status

Discontinued

2008
18 Mar
Discontinued Application: 77888

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

77888 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

77888

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

Regulatory Status

Discontinued

2008
18 Mar
Discontinued Application: 78024

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

78024 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

78024

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

Regulatory Status

Discontinued

2008
18 Mar
Discontinued Application: 78024

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

78024 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

78024

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

Regulatory Status

Discontinued

2017
20 Apr
RX Application: 208083

Drug Name

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/50ML (EQ 6MG BASE/ML)

Approval Date

2017-04-20

208083 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208083

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/50ML (EQ 6MG BASE/ML)

Approval Date

2017-04-20

Regulatory Status

RX

2017
20 Apr
RX Application: 208083

Drug Name

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 600MG BASE/50ML (EQ 12MG BASE/ML)

Approval Date

2017-04-20

208083 / 2

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208083

Product Number

2

Dosage Form

-

Strength

EQ 600MG BASE/50ML (EQ 12MG BASE/ML)

Approval Date

2017-04-20

Regulatory Status

RX

2017
20 Apr
RX Application: 208083

Drug Name

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 900MG BASE/50ML (EQ 18MG BASE/ML)

Approval Date

2017-04-20

208083 / 3

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208083

Product Number

3

Dosage Form

-

Strength

EQ 900MG BASE/50ML (EQ 18MG BASE/ML)

Approval Date

2017-04-20

Regulatory Status

RX

2017
28 Jun
RX Application: 208084

Drug Name

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2017-06-28

208084 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208084

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2017-06-28

Regulatory Status

RX

2017
28 Jun
RX Application: 208084

Drug Name

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

2017-06-28

208084 / 2

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208084

Product Number

2

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

2017-06-28

Regulatory Status

RX

2017
28 Jun
RX Application: 208084

Drug Name

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 18MG BASE/ML

Approval Date

2017-06-28

208084 / 3

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

208084

Product Number

3

Dosage Form

-

Strength

EQ 18MG BASE/ML

Approval Date

2017-06-28

Regulatory Status

RX

1989
29 Dec
Discontinued Application: 50648

Drug Name

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

1989-12-29

50648 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

50648

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989
29 Dec
Discontinued Application: 50648

Drug Name

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

1989-12-29

50648 / 2

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

50648

Product Number

2

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989
29 Dec
Discontinued Application: 50648

Drug Name

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 900MG BASE/100ML

Approval Date

1989-12-29

50648 / 3

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

50648

Product Number

3

Dosage Form

-

Strength

EQ 900MG BASE/100ML

Approval Date

1989-12-29

Regulatory Status

Discontinued

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2.75%;10GM/100ML

Approval Date

1997-09-29

20734 / 2

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

2

Dosage Form

-

Strength

2.75%;10GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

2.75%;25GM/100ML

Approval Date

1997-09-29

20734 / 5

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

5

Dosage Form

-

Strength

2.75%;25GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.75%;5GM/100ML

Approval Date

1997-09-29

20734 / 1

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

1

Dosage Form

-

Strength

2.75%;5GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

4.25%;10GM/100ML

Approval Date

1997-09-29

20734 / 8

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

8

Dosage Form

-

Strength

4.25%;10GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

4.25%;20GM/100ML

Approval Date

1997-09-29

20734 / 10

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

10

Dosage Form

-

Strength

4.25%;20GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

11

Dosage Form

-

Strength

4.25%;25GM/100ML

Approval Date

1997-09-29

20734 / 11

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

11

Dosage Form

-

Strength

4.25%;25GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

4.25%;5GM/100ML

Approval Date

1997-09-29

20734 / 7

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

7

Dosage Form

-

Strength

4.25%;5GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

14

Dosage Form

-

Strength

5%;10GM/100ML

Approval Date

1997-09-29

20734 / 14

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

14

Dosage Form

-

Strength

5%;10GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER

Product Number

15

Dosage Form

-

Strength

5%;15GM/100ML

Approval Date

1997-09-29

20734 / 15

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

15

Dosage Form

-

Strength

5%;15GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

16

Dosage Form

-

Strength

5%;20GM/100ML

Approval Date

1997-09-29

20734 / 16

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

16

Dosage Form

-

Strength

5%;20GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

17

Dosage Form

-

Strength

5%;25GM/100ML

Approval Date

1997-09-29

20734 / 17

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

17

Dosage Form

-

Strength

5%;25GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

1997
29 Sep
RX Application: 20734

Drug Name

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER

Product Number

18

Dosage Form

-

Strength

5%;35GM/100ML

Approval Date

1997-09-29

20734 / 18

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

18

Dosage Form

-

Strength

5%;35GM/100ML

Approval Date

1997-09-29

Regulatory Status

RX

2021
13 Apr
RX Application: 20734

Drug Name

CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER

Product Number

19

Dosage Form

-

Strength

8%;14GM/100ML

Approval Date

2021-04-13

20734 / 19

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

20734

Product Number

19

Dosage Form

-

Strength

8%;14GM/100ML

Approval Date

2021-04-13

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML

Approval Date

1997-03-26

20678 / 2

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

2

Dosage Form

-

Strength

2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML

Approval Date

1997-03-26

20678 / 5

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

5

Dosage Form

-

Strength

2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML

Approval Date

1997-03-26

20678 / 1

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

1

Dosage Form

-

Strength

2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

20678 / 9

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

9

Dosage Form

-

Strength

4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

11

Dosage Form

-

Strength

4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

20678 / 11

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

11

Dosage Form

-

Strength

4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

12

Dosage Form

-

Strength

4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

20678 / 12

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

12

Dosage Form

-

Strength

4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

20678 / 8

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

8

Dosage Form

-

Strength

4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

16

Dosage Form

-

Strength

5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

20678 / 16

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

16

Dosage Form

-

Strength

5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

17

Dosage Form

-

Strength

5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

20678 / 17

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

17

Dosage Form

-

Strength

5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER

Product Number

18

Dosage Form

-

Strength

5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

20678 / 18

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

18

Dosage Form

-

Strength

5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

19

Dosage Form

-

Strength

5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

20678 / 19

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

19

Dosage Form

-

Strength

5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1997
26 Mar
RX Application: 20678

Drug Name

CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

21

Dosage Form

-

Strength

5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

20678 / 21

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20678

Product Number

21

Dosage Form

-

Strength

5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML

Approval Date

1997-03-26

Regulatory Status

RX

1996
30 Aug
RX Application: 20512

Drug Name

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

15% (15GM/100ML)

Approval Date

1996-08-30

20512 / 1

Active Ingredient

AMINO ACIDS

Application Number

20512

Product Number

1

Dosage Form

-

Strength

15% (15GM/100ML)

Approval Date

1996-08-30

Regulatory Status

RX

2013
03 Oct
RX Application: 204508

Drug Name

CLINOLIPID 20%

Product Number

1

Dosage Form

-

Strength

16%(160GM/1000ML);4% (40GM/1000ML)

Approval Date

2013-10-03

204508 / 1

Active Ingredient

OLIVE OIL; SOYBEAN OIL

Application Number

204508

Product Number

1

Dosage Form

-

Strength

16%(160GM/1000ML);4% (40GM/1000ML)

Approval Date

2013-10-03

Regulatory Status

RX

2008
21 May
RX Application: 40745

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2008-05-21

40745 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

40745

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2008-05-21

Regulatory Status

RX

2008
21 May
RX Application: 40745

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2008-05-21

40745 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

40745

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2008-05-21

Regulatory Status

RX

2008
21 May
RX Application: 40745

Drug Name

CYCLOPHOSPHAMIDE

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2008-05-21

40745 / 3

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

40745

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2008-05-21

Regulatory Status

RX

1986
03 Jul
Discontinued Application: 88371

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1986-07-03

88371 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

88371

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1986-07-03

Regulatory Status

Discontinued

1986
03 Jul
Discontinued Application: 88372

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

1986-07-03

88372 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

88372

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

1986-07-03

Regulatory Status

Discontinued

1986
03 Jul
Discontinued Application: 88373

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1986-07-03

88373 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

88373

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1986-07-03

Regulatory Status

Discontinued

1986
24 Sep
Discontinued Application: 88374

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-09-24

88374 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

88374

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-09-24

Regulatory Status

Discontinued

2023
28 Jun
RX Application: 217651

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

500MG/2.5ML (200MG/ML)

Approval Date

2023-06-28

217651 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

217651

Product Number

1

Dosage Form

-

Strength

500MG/2.5ML (200MG/ML)

Approval Date

2023-06-28

Regulatory Status

RX

2023
28 Jun
RX Application: 217651

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

1GM/5ML (200MG/ML)

Approval Date

2023-06-28

217651 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

217651

Product Number

2

Dosage Form

-

Strength

1GM/5ML (200MG/ML)

Approval Date

2023-06-28

Regulatory Status

RX

1982
01 Jan
RX Application: 12141

Drug Name

CYTOXAN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

12141 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12141

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 12141

Drug Name

CYTOXAN

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

12141 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12141

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 12142

Drug Name

CYTOXAN

Product Number

1

Dosage Form

-

Strength

100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12142 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

1

Dosage Form

-

Strength

100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12142

Drug Name

CYTOXAN

Product Number

2

Dosage Form

-

Strength

200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12142 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

2

Dosage Form

-

Strength

200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12142

Drug Name

CYTOXAN (LYOPHILIZED)

Product Number

3

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12142 / 3

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

3

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
30 Aug
Discontinued Application: 12142

Drug Name

CYTOXAN (LYOPHILIZED)

Product Number

4

Dosage Form

-

Strength

1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-08-30

12142 / 4

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

4

Dosage Form

-

Strength

1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-08-30

Regulatory Status

Discontinued

1982
30 Aug
Discontinued Application: 12142

Drug Name

CYTOXAN (LYOPHILIZED)

Product Number

5

Dosage Form

-

Strength

2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-08-30

12142 / 5

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

5

Dosage Form

-

Strength

2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-08-30

Regulatory Status

Discontinued

1984
04 Jan
Discontinued Application: 12142

Drug Name

CYTOXAN (LYOPHILIZED)

Product Number

8

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-01-04

12142 / 8

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

8

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-01-04

Regulatory Status

Discontinued

1985
10 Dec
Discontinued Application: 12142

Drug Name

CYTOXAN (LYOPHILIZED)

Product Number

9

Dosage Form

-

Strength

2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-10

12142 / 9

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

9

Dosage Form

-

Strength

2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-10

Regulatory Status

Discontinued

1985
24 Sep
Discontinued Application: 12142

Drug Name

CYTOXAN (LYOPHILIZED)

Product Number

10

Dosage Form

-

Strength

1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-09-24

12142 / 10

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

10

Dosage Form

-

Strength

1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-09-24

Regulatory Status

Discontinued

2023
27 Feb
RX Application: 213645

Drug Name

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

350MG/50ML (7MG/ML)

Approval Date

2023-02-27

213645 / 2

Active Ingredient

DAPTOMYCIN

Application Number

213645

Product Number

2

Dosage Form

-

Strength

350MG/50ML (7MG/ML)

Approval Date

2023-02-27

Regulatory Status

RX

2023
27 Feb
RX Application: 213645

Drug Name

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG/50ML (10MG/ML)

Approval Date

2023-02-27

213645 / 3

Active Ingredient

DAPTOMYCIN

Application Number

213645

Product Number

3

Dosage Form

-

Strength

500MG/50ML (10MG/ML)

Approval Date

2023-02-27

Regulatory Status

RX

2023
27 Feb
RX Application: 213645

Drug Name

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Product Number

4

Dosage Form

-

Strength

700MG/100ML (7MG/ML)

Approval Date

2023-02-27

213645 / 4

Active Ingredient

DAPTOMYCIN

Application Number

213645

Product Number

4

Dosage Form

-

Strength

700MG/100ML (7MG/ML)

Approval Date

2023-02-27

Regulatory Status

RX

2023
27 Feb
RX Application: 213645

Drug Name

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Product Number

5

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-02-27

213645 / 5

Active Ingredient

DAPTOMYCIN

Application Number

213645

Product Number

5

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-02-27

Regulatory Status

RX

2022
25 Jan
Discontinued Application: 213645

Drug Name

DAPZURA RT

Product Number

1

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2022-01-25

213645 / 1

Active Ingredient

DAPTOMYCIN

Application Number

213645

Product Number

1

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2022-01-25

Regulatory Status

Discontinued

2026
15 Apr
RX Application: 208103

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2026-04-15

208103 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

208103

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2026-04-15

Regulatory Status

RX

2018
21 Aug
RX Application: 208532

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2018-08-21

208532 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

208532

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2018-08-21

Regulatory Status

RX

2018
21 Aug
RX Application: 208532

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2018-08-21

208532 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

208532

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2018-08-21

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 16696

Drug Name

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

10GM/100ML;900MG/100ML

Approval Date

1982-01-01

16696 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

16696

Product Number

1

Dosage Form

-

Strength

10GM/100ML;900MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 16694

Drug Name

DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

16694 / 1

Active Ingredient

DEXTROSE

Application Number

16694

Product Number

1

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16697

Drug Name

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.5GM/100ML;450MG/100ML

Approval Date

1982-01-01

16697 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

16697

Product Number

1

Dosage Form

-

Strength

2.5GM/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17521

Drug Name

DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17521 / 4

Active Ingredient

DEXTROSE

Application Number

17521

Product Number

4

Dosage Form

-

Strength

20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17521

Drug Name

DEXTROSE 30% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17521 / 3

Active Ingredient

DEXTROSE

Application Number

17521

Product Number

3

Dosage Form

-

Strength

30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17521

Drug Name

DEXTROSE 40% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17521 / 2

Active Ingredient

DEXTROSE

Application Number

17521

Product Number

2

Dosage Form

-

Strength

40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17484

Drug Name

DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML

Approval Date

1982-01-01

17484 / 1

Active Ingredient

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

17484

Product Number

1

Dosage Form

-

Strength

5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1983
29 Jun
Discontinued Application: 18840

Drug Name

DEXTROSE 5% AND ELECTROLYTE NO. 75 IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;205MG/100ML;100MG/100ML;120MG/100ML;220MG/100ML

Approval Date

1983-06-29

18840 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

18840

Product Number

1

Dosage Form

-

Strength

5GM/100ML;205MG/100ML;100MG/100ML;120MG/100ML;220MG/100ML

Approval Date

1983-06-29

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17634

Drug Name

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5GM/100ML;75MG/100ML

Approval Date

1982-01-01

17634 / 4

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE

Application Number

17634

Product Number

4

Dosage Form

-

Strength

5GM/100ML;75MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17634

Drug Name

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;150MG/100ML

Approval Date

1982-01-01

17634 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE

Application Number

17634

Product Number

1

Dosage Form

-

Strength

5GM/100ML;150MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17634

Drug Name

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

5GM/100ML;224MG/100ML

Approval Date

1982-01-01

17634 / 3

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE

Application Number

17634

Product Number

3

Dosage Form

-

Strength

5GM/100ML;224MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17634

Drug Name

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5GM/100ML;300MG/100ML

Approval Date

1982-01-01

17634 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE

Application Number

17634

Product Number

2

Dosage Form

-

Strength

5GM/100ML;300MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16673

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

16673 / 1

Active Ingredient

DEXTROSE

Application Number

16673

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1985
30 Oct
RX Application: 16673

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

50MG/ML

Approval Date

1985-10-30

16673 / 3

Active Ingredient

DEXTROSE

Application Number

16673

Product Number

3

Dosage Form

-

Strength

50MG/ML

Approval Date

1985-10-30

Regulatory Status

RX

1992
07 Dec
RX Application: 20179

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1992-12-07

20179 / 1

Active Ingredient

DEXTROSE

Application Number

20179

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1992-12-07

Regulatory Status

RX

1992
07 Dec
RX Application: 20179

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1992-12-07

20179 / 2

Active Ingredient

DEXTROSE

Application Number

20179

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1992-12-07

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 16695

Drug Name

DEXTROSE 5% IN RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-01-01

16695 / 1

Active Ingredient

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

16695

Product Number

1

Dosage Form

-

Strength

33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 16689

Drug Name

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;200MG/100ML

Approval Date

1982-01-01

16689 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

16689

Product Number

1

Dosage Form

-

Strength

5GM/100ML;200MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16687

Drug Name

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;330MG/100ML

Approval Date

1982-01-01

16687 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

16687

Product Number

1

Dosage Form

-

Strength

5GM/100ML;330MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16683

Drug Name

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;450MG/100ML

Approval Date

1982-01-01

16683 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

16683

Product Number

1

Dosage Form

-

Strength

5GM/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16678

Drug Name

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;900MG/100ML

Approval Date

1982-01-01

16678 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

16678

Product Number

1

Dosage Form

-

Strength

5GM/100ML;900MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
13 Apr
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ

Product Number

6

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;200MG/100ML

Approval Date

1982-04-13

18037 / 6

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

6

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;200MG/100ML

Approval Date

1982-04-13

Regulatory Status

RX

1982
13 Apr
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ

Product Number

7

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;200MG/100ML

Approval Date

1982-04-13

18037 / 7

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

7

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;200MG/100ML

Approval Date

1982-04-13

Regulatory Status

RX

1982
01 Jan
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)

Product Number

4

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;200MG/100ML

Approval Date

1982-01-01

18037 / 4

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

4

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;200MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
13 Apr
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ

Product Number

8

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;200MG/100ML

Approval Date

1982-04-13

18037 / 8

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

8

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;200MG/100ML

Approval Date

1982-04-13

Regulatory Status

RX

1982
01 Jan
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)

Product Number

1

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;200MG/100ML

Approval Date

1982-01-01

18037 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

1

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;200MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
13 Apr
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ

Product Number

5

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;200MG/100ML

Approval Date

1982-04-13

18037 / 5

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

5

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;200MG/100ML

Approval Date

1982-04-13

Regulatory Status

RX

1982
13 Apr
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ

Product Number

9

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;200MG/100ML

Approval Date

1982-04-13

18037 / 9

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

9

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;200MG/100ML

Approval Date

1982-04-13

Regulatory Status

RX

1982
01 Jan
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ

Product Number

2

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;200MG/100ML

Approval Date

1982-01-01

18037 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

2

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;200MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18037

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)

Product Number

3

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;200MG/100ML

Approval Date

1982-01-01

18037 / 3

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18037

Product Number

3

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;200MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

2

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 5

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

5

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 3

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

3

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 4

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

4

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 6

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

6

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 7

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

7

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 8

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

8

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
23 Mar
RX Application: 18629

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;330MG/100ML

Approval Date

1982-03-23

18629 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18629

Product Number

1

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;330MG/100ML

Approval Date

1982-03-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18008

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18008 / 3

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18008

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;450MG/100ML

Approval Date

1982-01-01

18008 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

1

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 18008

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;450MG/100ML

Approval Date

1982-01-01

18008 / 10

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

10

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18008

Drug Name

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;450MG/100ML

Approval Date

1982-01-01

18008 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

2

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17521

Drug Name

DEXTROSE 50% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17521 / 1

Active Ingredient

DEXTROSE

Application Number

17521

Product Number

1

Dosage Form

-

Strength

50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
02 Jul
RX Application: 20047

Drug Name

DEXTROSE 50% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

50GM/100ML

Approval Date

1991-07-02

20047 / 1

Active Ingredient

DEXTROSE

Application Number

20047

Product Number

1

Dosage Form

-

Strength

50GM/100ML

Approval Date

1991-07-02

Regulatory Status

RX

1982
26 Mar
Discontinued Application: 17521

Drug Name

DEXTROSE 60% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-26

17521 / 5

Active Ingredient

DEXTROSE

Application Number

17521

Product Number

5

Dosage Form

-

Strength

60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-26

Regulatory Status

Discontinued

1991
02 Jul
Discontinued Application: 20047

Drug Name

DEXTROSE 60% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

60GM/100ML

Approval Date

1991-07-02

20047 / 2

Active Ingredient

DEXTROSE

Application Number

20047

Product Number

2

Dosage Form

-

Strength

60GM/100ML

Approval Date

1991-07-02

Regulatory Status

Discontinued

1982
26 Mar
Discontinued Application: 17521

Drug Name

DEXTROSE 70% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

70GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-26

17521 / 6

Active Ingredient

DEXTROSE

Application Number

17521

Product Number

6

Dosage Form

-

Strength

70GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-26

Regulatory Status

Discontinued

1991
02 Jul
RX Application: 20047

Drug Name

DEXTROSE 70% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

70GM/100ML

Approval Date

1991-07-02

20047 / 3

Active Ingredient

DEXTROSE

Application Number

20047

Product Number

3

Dosage Form

-

Strength

70GM/100ML

Approval Date

1991-07-02

Regulatory Status

RX

2026
28 Jul
RX Application: 219882

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2026-07-28

219882 / 1

Active Ingredient

DIAZEPAM

Application Number

219882

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 219882

Drug Name

DIAZEPAM

Product Number

2

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2026-07-28

219882 / 2

Active Ingredient

DIAZEPAM

Application Number

219882

Product Number

2

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2025
07 Jan
Discontinued Application: 216747

Drug Name

DIHYDROERGOTAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2025-01-07

216747 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE

Application Number

216747

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2025-01-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84767

Drug Name

DIMENHYDRINATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

84767 / 1

Active Ingredient

DIMENHYDRINATE

Application Number

84767

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
26 Sep
Discontinued Application: 74381

Drug Name

DOBUTAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1996-09-26

74381 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

74381

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1996-09-26

Regulatory Status

Discontinued

1993
19 Oct
RX Application: 20255

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

20255 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20255

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20255

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

20255 / 3

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20255

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20255

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

20255 / 4

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20255

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20255

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE/100ML

Approval Date

1993-10-19

20255 / 5

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20255

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18398

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

18398 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18398

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
22 Mar
Discontinued Application: 18398

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-03-22

18398 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18398

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-03-22

Regulatory Status

Discontinued

1987
27 Mar
RX Application: 19615

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

80MG/100ML

Approval Date

1987-03-27

19615 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

19615

Product Number

1

Dosage Form

-

Strength

80MG/100ML

Approval Date

1987-03-27

Regulatory Status

RX

1987
27 Mar
RX Application: 19615

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

160MG/100ML

Approval Date

1987-03-27

19615 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

19615

Product Number

2

Dosage Form

-

Strength

160MG/100ML

Approval Date

1987-03-27

Regulatory Status

RX

1987
27 Mar
RX Application: 19615

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

320MG/100ML

Approval Date

1987-03-27

19615 / 3

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

19615

Product Number

3

Dosage Form

-

Strength

320MG/100ML

Approval Date

1987-03-27

Regulatory Status

RX

1987
27 Mar
RX Application: 19615

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

640MG/100ML

Approval Date

1987-03-27

19615 / 4

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

19615

Product Number

4

Dosage Form

-

Strength

640MG/100ML

Approval Date

1987-03-27

Regulatory Status

RX

1995
17 Nov
RX Application: 50718

Drug Name

DOXIL (LIPOSOMAL)

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

1995-11-17

50718 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

50718

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

1995-11-17

Regulatory Status

RX

2000
13 Jun
RX Application: 50718

Drug Name

DOXIL (LIPOSOMAL)

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2000-06-13

50718 / 2

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

50718

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2000-06-13

Regulatory Status

RX

2022
19 Oct
RX Application: 212219

Drug Name

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2022-10-19

212219 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

212219

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2022-10-19

Regulatory Status

RX

2022
19 Oct
RX Application: 212219

Drug Name

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2022-10-19

212219 / 2

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

212219

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2022-10-19

Regulatory Status

RX

2026
08 Jul
RX Application: 216740

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2026-07-08

216740 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

216740

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2026-07-08

Regulatory Status

RX

2026
30 Mar
RX Application: 220626

Drug Name

EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2026-03-30

220626 / 1

Active Ingredient

EPINEPHRINE

Application Number

220626

Product Number

1

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2026-03-30

Regulatory Status

RX

2026
30 Mar
RX Application: 220626

Drug Name

EPINEPHRINE

Product Number

2

Dosage Form

-

Strength

30MG/30ML (1MG/ML)

Approval Date

2026-03-30

220626 / 2

Active Ingredient

EPINEPHRINE

Application Number

220626

Product Number

2

Dosage Form

-

Strength

30MG/30ML (1MG/ML)

Approval Date

2026-03-30

Regulatory Status

RX

2025
28 Feb
Discontinued Application: 218475

Drug Name

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

Approval Date

2025-02-28

218475 / 1

Active Ingredient

EPINEPHRINE BITARTRATE

Application Number

218475

Product Number

1

Dosage Form

-

Strength

EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

Approval Date

2025-02-28

Regulatory Status

Discontinued

2026
16 Mar
RX Application: 218475

Drug Name

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Approval Date

2026-03-16

218475 / 2

Active Ingredient

EPINEPHRINE BITARTRATE

Application Number

218475

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Approval Date

2026-03-16

Regulatory Status

RX

2018
23 Nov
Discontinued Application: 208554

Drug Name

EPTIFIBATIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2018-11-23

208554 / 1

Active Ingredient

EPTIFIBATIDE

Application Number

208554

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2018-11-23

Regulatory Status

Discontinued

2018
23 Nov
RX Application: 208554

Drug Name

EPTIFIBATIDE

Product Number

2

Dosage Form

-

Strength

75MG/100ML

Approval Date

2018-11-23

208554 / 2

Active Ingredient

EPTIFIBATIDE

Application Number

208554

Product Number

2

Dosage Form

-

Strength

75MG/100ML

Approval Date

2018-11-23

Regulatory Status

RX

2024
01 Oct
RX Application: 217250

Drug Name

ERIBULIN MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2024-10-01

217250 / 1

Active Ingredient

ERIBULIN MESYLATE

Application Number

217250

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2024-10-01

Regulatory Status

RX

1989
09 May
Discontinued Application: 62993

Drug Name

ERYTHROMYCIN LACTOBIONATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1989-05-09

62993 / 1

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

62993

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1989-05-09

Regulatory Status

Discontinued

1989
09 May
Discontinued Application: 62993

Drug Name

ERYTHROMYCIN LACTOBIONATE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1989-05-09

62993 / 2

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

62993

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1989-05-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17087

Drug Name

ETHRANE

Product Number

1

Dosage Form

-

Strength

99.9% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17087 / 1

Active Ingredient

ENFLURANE

Application Number

17087

Product Number

1

Dosage Form

-

Strength

99.9% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2001
10 May
RX Application: 75591

Drug Name

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2001-05-10

75591 / 1

Active Ingredient

FAMOTIDINE

Application Number

75591

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2001-05-10

Regulatory Status

RX

1982
01 Jan
RX Application: 18657

Drug Name

FLAGYL I.V. RTU IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

500MG/100ML

Approval Date

1982-01-01

18657 / 1

Active Ingredient

METRONIDAZOLE

Application Number

18657

Product Number

1

Dosage Form

-

Strength

500MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

2010
26 May
Discontinued Application: 77947

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2010-05-26

77947 / 1

Active Ingredient

FLUCONAZOLE

Application Number

77947

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2010-05-26

Regulatory Status

Discontinued

2010
26 May
Discontinued Application: 77947

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2010-05-26

77947 / 2

Active Ingredient

FLUCONAZOLE

Application Number

77947

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2010-05-26

Regulatory Status

Discontinued

2004
29 Jul
RX Application: 76766

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

76766 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76766

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2004
29 Jul
RX Application: 76766

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

76766 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76766

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2004
12 Oct
RX Application: 76755

Drug Name

FLUMAZENIL

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

76755 / 1

Active Ingredient

FLUMAZENIL

Application Number

76755

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

RX

2004
12 Oct
RX Application: 76755

Drug Name

FLUMAZENIL

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

76755 / 2

Active Ingredient

FLUMAZENIL

Application Number

76755

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

RX

1982
01 Jan
RX Application: 17624

Drug Name

FORANE

Product Number

1

Dosage Form

-

Strength

99.9%

Approval Date

1982-01-01

17624 / 1

Active Ingredient

ISOFLURANE

Application Number

17624

Product Number

1

Dosage Form

-

Strength

99.9%

Approval Date

1982-01-01

Regulatory Status

RX

2019
05 Sep
Discontinued Application: 211860

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

211860 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

211860

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

Discontinued

2014
27 Jan
RX Application: 202747

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2014-01-27

202747 / 1

Active Ingredient

FUROSEMIDE

Application Number

202747

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2014-01-27

Regulatory Status

RX

1982
07 Sep
Discontinued Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.8MG BASE/ML

Approval Date

1982-09-07

62373 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

1

Dosage Form

-

Strength

EQ 0.8MG BASE/ML

Approval Date

1982-09-07

Regulatory Status

Discontinued

1982
07 Sep
RX Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1982-09-07

62373 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

2

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1982-09-07

Regulatory Status

RX

1982
07 Sep
Discontinued Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE/100ML

Approval Date

1982-09-07

62373 / 3

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE/100ML

Approval Date

1982-09-07

Regulatory Status

Discontinued

1982
07 Sep
Discontinued Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE/100ML

Approval Date

1982-09-07

62373 / 4

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE/100ML

Approval Date

1982-09-07

Regulatory Status

Discontinued

1982
07 Sep
RX Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1982-09-07

62373 / 5

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1982-09-07

Regulatory Status

RX

1982
07 Sep
RX Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 120MG BASE/100ML

Approval Date

1982-09-07

62373 / 6

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

6

Dosage Form

-

Strength

EQ 120MG BASE/100ML

Approval Date

1982-09-07

Regulatory Status

RX

1982
07 Sep
RX Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1982-09-07

62373 / 7

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

7

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1982-09-07

Regulatory Status

RX

1982
07 Sep
RX Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1982-09-07

62373 / 8

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

8

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1982-09-07

Regulatory Status

RX

1982
07 Sep
RX Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1982-09-07

62373 / 9

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

9

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1982-09-07

Regulatory Status

RX

1982
07 Sep
Discontinued Application: 62373

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

EQ 2.4MG BASE/ML

Approval Date

1982-09-07

62373 / 10

Active Ingredient

GENTAMICIN SULFATE

Application Number

62373

Product Number

10

Dosage Form

-

Strength

EQ 2.4MG BASE/ML

Approval Date

1982-09-07

Regulatory Status

Discontinued

1982
19 Feb
Discontinued Application: 18522

Drug Name

GLYCINE 1.5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1.5GM/100ML

Approval Date

1982-02-19

18522 / 1

Active Ingredient

GLYCINE

Application Number

18522

Product Number

1

Dosage Form

-

Strength

1.5GM/100ML

Approval Date

1982-02-19

Regulatory Status

Discontinued

2007
31 Dec
Discontinued Application: 78197

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2007-12-31

78197 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78197

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2007-12-31

Regulatory Status

Discontinued

2008
30 Jun
Discontinued Application: 78198

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-06-30

78198 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78198

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-06-30

Regulatory Status

Discontinued

2008
30 Jun
Discontinued Application: 78198

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2008-06-30

78198 / 2

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78198

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2008-06-30

Regulatory Status

Discontinued

2004
25 Aug
Discontinued Application: 76791

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2004-08-25

76791 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

76791

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2004-08-25

Regulatory Status

Discontinued

2004
25 Aug
Discontinued Application: 76828

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2004-08-25

76828 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

76828

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2004-08-25

Regulatory Status

Discontinued

1982
28 Apr
RX Application: 18609

Drug Name

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

Product Number

1

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1982-04-28

18609 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

18609

Product Number

1

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1982-04-28

Regulatory Status

RX

1985
09 Jul
Discontinued Application: 18814

Drug Name

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

Product Number

2

Dosage Form

-

Strength

2,000 UNITS/100ML

Approval Date

1985-07-09

18814 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

18814

Product Number

2

Dosage Form

-

Strength

2,000 UNITS/100ML

Approval Date

1985-07-09

Regulatory Status

Discontinued

1982
28 Apr
RX Application: 18609

Drug Name

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

Product Number

2

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1982-04-28

18609 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

18609

Product Number

2

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1982-04-28

Regulatory Status

RX

-
Unclassified Application: 18609

Drug Name

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

Product Number

4

Dosage Form

-

Strength

2,000 UNITS/1000ML

Approval Date

-

18609 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

18609

Product Number

4

Dosage Form

-

Strength

2,000 UNITS/1000ML

Approval Date

-

Regulatory Status

Unclassified

1983
31 Oct
Discontinued Application: 18814

Drug Name

HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4,000 UNITS/100ML

Approval Date

1983-10-31

18814 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

18814

Product Number

1

Dosage Form

-

Strength

4,000 UNITS/100ML

Approval Date

1983-10-31

Regulatory Status

Discontinued

1985
09 Jul
Discontinued Application: 18814

Drug Name

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

Product Number

3

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-07-09

18814 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

18814

Product Number

3

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-07-09

Regulatory Status

Discontinued

1987
02 Jul
Discontinued Application: 18814

Drug Name

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

Product Number

4

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1987-07-02

18814 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

18814

Product Number

4

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1987-07-02

Regulatory Status

Discontinued

1982
28 Apr
Discontinued Application: 18609

Drug Name

HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

500 UNITS/100ML

Approval Date

1982-04-28

18609 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

18609

Product Number

3

Dosage Form

-

Strength

500 UNITS/100ML

Approval Date

1982-04-28

Regulatory Status

Discontinued

1996
04 Apr
Discontinued Application: 20360

Drug Name

HEPATASOL 8%

Product Number

1

Dosage Form

-

Strength

8% (8GM/100ML)

Approval Date

1996-04-04

20360 / 1

Active Ingredient

AMINO ACIDS

Application Number

20360

Product Number

1

Dosage Form

-

Strength

8% (8GM/100ML)

Approval Date

1996-04-04

Regulatory Status

Discontinued

2025
17 Jul
RX Application: 219797

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2025-07-17

219797 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

219797

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2025-07-17

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 86619

Drug Name

HYDROCORTISONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1982-01-01

86619 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

86619

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87567

Drug Name

HYDROCORTISONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

87567 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

87567

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87568

Drug Name

HYDROCORTISONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

87568 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

87568

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87569

Drug Name

HYDROCORTISONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

87569 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

87569

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85551

Drug Name

HYDROXYZINE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

85551 / 2

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

85551

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85551

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

85551 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

85551

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
30 Dec
RX Application: 19763

Drug Name

IFEX

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1988-12-30

19763 / 1

Active Ingredient

IFOSFAMIDE

Application Number

19763

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1988-12-30

Regulatory Status

RX

1988
30 Dec
RX Application: 19763

Drug Name

IFEX

Product Number

2

Dosage Form

-

Strength

3GM/VIAL

Approval Date

1988-12-30

19763 / 2

Active Ingredient

IFOSFAMIDE

Application Number

19763

Product Number

2

Dosage Form

-

Strength

3GM/VIAL

Approval Date

1988-12-30

Regulatory Status

RX

1992
10 Oct
Discontinued Application: 19763

Drug Name

IFEX/MESNEX KIT

Product Number

3

Dosage Form

-

Strength

1GM/VIAL;100MG/ML

Approval Date

1992-10-10

19763 / 3

Active Ingredient

IFOSFAMIDE; MESNA

Application Number

19763

Product Number

3

Dosage Form

-

Strength

1GM/VIAL;100MG/ML

Approval Date

1992-10-10

Regulatory Status

Discontinued

1992
10 Oct
Discontinued Application: 19763

Drug Name

IFEX/MESNEX KIT

Product Number

4

Dosage Form

-

Strength

3GM/VIAL;100MG/ML

Approval Date

1992-10-10

19763 / 4

Active Ingredient

IFOSFAMIDE; MESNA

Application Number

19763

Product Number

4

Dosage Form

-

Strength

3GM/VIAL;100MG/ML

Approval Date

1992-10-10

Regulatory Status

Discontinued

1996
06 Nov
Discontinued Application: 74629

Drug Name

IOPAMIDOL

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1996-11-06

74629 / 1

Active Ingredient

IOPAMIDOL

Application Number

74629

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1996-11-06

Regulatory Status

Discontinued

1996
06 Nov
Discontinued Application: 74629

Drug Name

IOPAMIDOL

Product Number

2

Dosage Form

-

Strength

61%

Approval Date

1996-11-06

74629 / 2

Active Ingredient

IOPAMIDOL

Application Number

74629

Product Number

2

Dosage Form

-

Strength

61%

Approval Date

1996-11-06

Regulatory Status

Discontinued

1996
06 Nov
Discontinued Application: 74629

Drug Name

IOPAMIDOL

Product Number

3

Dosage Form

-

Strength

76%

Approval Date

1996-11-06

74629 / 3

Active Ingredient

IOPAMIDOL

Application Number

74629

Product Number

3

Dosage Form

-

Strength

76%

Approval Date

1996-11-06

Regulatory Status

Discontinued

1998
31 Mar
Discontinued Application: 74629

Drug Name

IOPAMIDOL

Product Number

4

Dosage Form

-

Strength

51%

Approval Date

1998-03-31

74629 / 4

Active Ingredient

IOPAMIDOL

Application Number

74629

Product Number

4

Dosage Form

-

Strength

51%

Approval Date

1998-03-31

Regulatory Status

Discontinued

1982
22 Jun
Discontinued Application: 18519

Drug Name

IRRIGATING SOLUTION G IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3.24GM/100ML;380MG/100ML;430MG/100ML

Approval Date

1982-06-22

18519 / 1

Active Ingredient

CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE

Application Number

18519

Product Number

1

Dosage Form

-

Strength

3.24GM/100ML;380MG/100ML;430MG/100ML

Approval Date

1982-06-22

Regulatory Status

Discontinued

1983
29 Jul
Discontinued Application: 88144

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.08%

Approval Date

1983-07-29

88144 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88144

Product Number

1

Dosage Form

-

Strength

0.08%

Approval Date

1983-07-29

Regulatory Status

Discontinued

1984
26 Mar
Discontinued Application: 88145

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.14%

Approval Date

1984-03-26

88145 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88145

Product Number

1

Dosage Form

-

Strength

0.14%

Approval Date

1984-03-26

Regulatory Status

Discontinued

1983
01 Aug
Discontinued Application: 88146

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1983-08-01

88146 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88146

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1983-08-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83486

Drug Name

ISOPROTERENOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

83486 / 1

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

83486

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2025
17 Sep
Discontinued Application: 219684

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2025-09-17

219684 / 1

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

219684

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2025-09-17

Regulatory Status

Discontinued

2026
11 Aug
RX Application: 219684

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/5ML (EQ 10MG BASE/ML)

Approval Date

2026-08-11

219684 / 2

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

219684

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/5ML (EQ 10MG BASE/ML)

Approval Date

2026-08-11

Regulatory Status

RX

2001
29 Jun
Discontinued Application: 75631

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2001-06-29

75631 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75631

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2001-06-29

Regulatory Status

Discontinued

2001
29 Jun
Discontinued Application: 75631

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

15MG/ML

Approval Date

2001-06-29

75631 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75631

Product Number

2

Dosage Form

-

Strength

15MG/ML

Approval Date

2001-06-29

Regulatory Status

Discontinued

2017
15 Sep
RX Application: 209900

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2017-09-15

209900 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

209900

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2017-09-15

Regulatory Status

RX

2018
25 Jul
RX Application: 209900

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

15MG/ML

Approval Date

2018-07-25

209900 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

209900

Product Number

2

Dosage Form

-

Strength

15MG/ML

Approval Date

2018-07-25

Regulatory Status

RX

2002
05 Jul
RX Application: 76051

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2002-07-05

76051 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

76051

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2002-07-05

Regulatory Status

RX

1982
01 Jan
RX Application: 16679

Drug Name

LACTATED RINGERS AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16679 / 1

Active Ingredient

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

Application Number

16679

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16682

Drug Name

LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16682 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

16682

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

RX

1982
19 Feb
RX Application: 18494

Drug Name

LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-02-19

18494 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

18494

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-02-19

Regulatory Status

RX

1984
03 Apr
RX Application: 18921

Drug Name

LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-04-03

18921 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

18921

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-04-03

Regulatory Status

RX

1989
29 Aug
Discontinued Application: 19933

Drug Name

LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-08-29

19933 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

19933

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-08-29

Regulatory Status

Discontinued

2026
06 Aug
RX Application: 208458

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2026-08-06

208458 / 1

Active Ingredient

LEVETIRACETAM

Application Number

208458

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2026-08-06

Regulatory Status

RX

2023
02 Oct
RX Application: 217059

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2023-10-02

217059 / 1

Active Ingredient

LEVETIRACETAM

Application Number

217059

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2023-10-02

Regulatory Status

RX

2023
02 Oct
RX Application: 217059

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-10-02

217059 / 2

Active Ingredient

LEVETIRACETAM

Application Number

217059

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2023-10-02

Regulatory Status

RX

2023
02 Oct
RX Application: 217059

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2023-10-02

217059 / 3

Active Ingredient

LEVETIRACETAM

Application Number

217059

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2023-10-02

Regulatory Status

RX

2026
02 Jul
RX Application: 217896

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2026-07-02

217896 / 1

Active Ingredient

LEVOCARNITINE

Application Number

217896

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2026-07-02

Regulatory Status

RX

2013
05 Jun
Discontinued Application: 91436

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-06-05

91436 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

91436

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-06-05

Regulatory Status

Discontinued

2013
08 Aug
Discontinued Application: 91397

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-08-08

91397 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

91397

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2013-08-08

Regulatory Status

Discontinued

2013
08 Aug
Discontinued Application: 91397

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-08-08

91397 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

91397

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-08-08

Regulatory Status

Discontinued

2013
08 Aug
Discontinued Application: 91397

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-08-08

91397 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

91397

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-08-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18461

Drug Name

LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100MG/100ML

Approval Date

1982-01-01

18461 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18461

Product Number

1

Dosage Form

-

Strength

100MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 18461

Drug Name

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-01-01

18461 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18461

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18461

Drug Name

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-01-01

18461 / 3

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18461

Product Number

3

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
22 Feb
RX Application: 18461

Drug Name

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

800MG/100ML

Approval Date

1982-02-22

18461 / 4

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18461

Product Number

4

Dosage Form

-

Strength

800MG/100ML

Approval Date

1982-02-22

Regulatory Status

RX

1985
05 Dec
Discontinued Application: 12142

Drug Name

LYOPHILIZED CYTOXAN

Product Number

6

Dosage Form

-

Strength

100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-05

12142 / 6

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

6

Dosage Form

-

Strength

100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-05

Regulatory Status

Discontinued

1985
10 Dec
Discontinued Application: 12142

Drug Name

LYOPHILIZED CYTOXAN

Product Number

7

Dosage Form

-

Strength

200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-10

12142 / 7

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

12142

Product Number

7

Dosage Form

-

Strength

200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-10

Regulatory Status

Discontinued

2026
08 Jan
RX Application: 211966

Drug Name

MAGNESIUM SULFATE

Product Number

4

Dosage Form

-

Strength

3GM/100ML (30MG/ML)

Approval Date

2026-01-08

211966 / 4

Active Ingredient

MAGNESIUM SULFATE

Application Number

211966

Product Number

4

Dosage Form

-

Strength

3GM/100ML (30MG/ML)

Approval Date

2026-01-08

Regulatory Status

RX

2020
11 Aug
RX Application: 211965

Drug Name

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

2020-08-11

211965 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

211965

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

2020-08-11

Regulatory Status

RX

2020
01 Jun
RX Application: 211966

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2020-06-01

211966 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

211966

Product Number

1

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2020-06-01

Regulatory Status

RX

2020
01 Jun
RX Application: 211966

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

2020-06-01

211966 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

211966

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

2020-06-01

Regulatory Status

RX

2020
01 Jun
RX Application: 211966

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

2020-06-01

211966 / 3

Active Ingredient

MAGNESIUM SULFATE

Application Number

211966

Product Number

3

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

2020-06-01

Regulatory Status

RX

1984
15 Jun
Discontinued Application: 88279

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1984-06-15

88279 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

88279

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1984-06-15

Regulatory Status

Discontinued

1984
15 Jun
Discontinued Application: 88280

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1984-06-15

88280 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

88280

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1984-06-15

Regulatory Status

Discontinued

1984
15 Jun
Discontinued Application: 88281

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

75MG/ML

Approval Date

1984-06-15

88281 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

88281

Product Number

1

Dosage Form

-

Strength

75MG/ML

Approval Date

1984-06-15

Regulatory Status

Discontinued

1984
15 Jun
Discontinued Application: 88282

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1984-06-15

88282 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

88282

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1984-06-15

Regulatory Status

Discontinued

1988
30 Dec
RX Application: 19884

Drug Name

MESNEX

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1988-12-30

19884 / 1

Active Ingredient

MESNA

Application Number

19884

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1988-12-30

Regulatory Status

RX

2002
21 Mar
RX Application: 20855

Drug Name

MESNEX

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-03-21

20855 / 1

Active Ingredient

MESNA

Application Number

20855

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2002-03-21

Regulatory Status

RX

2022
14 Jul
Discontinued Application: 215065

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2022-07-14

215065 / 1

Active Ingredient

METHOCARBAMOL

Application Number

215065

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2022-07-14

Regulatory Status

Discontinued

1986
01 Jul
Discontinued Application: 70291

Drug Name

METHYLDOPATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-07-01

70291 / 1

Active Ingredient

METHYLDOPATE HYDROCHLORIDE

Application Number

70291

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-07-01

Regulatory Status

Discontinued

2013
29 Apr
RX Application: 78950

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2013-04-29

78950 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

78950

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2013-04-29

Regulatory Status

RX

2008
31 Mar
Discontinued Application: 78084

Drug Name

METRONIDAZOLE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

500MG/100ML

Approval Date

2008-03-31

78084 / 1

Active Ingredient

METRONIDAZOLE

Application Number

78084

Product Number

1

Dosage Form

-

Strength

500MG/100ML

Approval Date

2008-03-31

Regulatory Status

Discontinued

2023
29 Sep
RX Application: 216142

Drug Name

MICAFUNGIN IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

Approval Date

2023-09-29

216142 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

216142

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

Approval Date

2023-09-29

Regulatory Status

RX

2023
29 Sep
RX Application: 216142

Drug Name

MICAFUNGIN IN SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML (EQ 1MG BASE/ML)

Approval Date

2023-09-29

216142 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

216142

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML (EQ 1MG BASE/ML)

Approval Date

2023-09-29

Regulatory Status

RX

2023
29 Sep
RX Application: 216142

Drug Name

MICAFUNGIN IN SODIUM CHLORIDE 0.9%

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE/150ML (EQ 1MG BASE/ML)

Approval Date

2023-09-29

216142 / 3

Active Ingredient

MICAFUNGIN SODIUM

Application Number

216142

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE/150ML (EQ 1MG BASE/ML)

Approval Date

2023-09-29

Regulatory Status

RX

2000
31 Oct
Discontinued Application: 75637

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-10-31

75637 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75637

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-10-31

Regulatory Status

Discontinued

2000
31 Oct
Discontinued Application: 75637

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-10-31

75637 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75637

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-10-31

Regulatory Status

Discontinued

2004
21 Sep
Discontinued Application: 76427

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2004-09-21

76427 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

76427

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2004-09-21

Regulatory Status

Discontinued

-
Unclassified Application: 76427

Drug Name

MILRINONE LACTATE

Product Number

2

Dosage Form

-

Strength

20MG/20ML

Approval Date

-

76427 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

76427

Product Number

2

Dosage Form

-

Strength

20MG/20ML

Approval Date

-

Regulatory Status

Unclassified

2002
28 May
RX Application: 75834

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2002-05-28

75834 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75834

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2002-05-28

Regulatory Status

RX

2002
28 May
RX Application: 75834

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2002-05-28

75834 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

75834

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2002-05-28

Regulatory Status

RX

2002
08 Aug
Discontinued Application: 76259

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2002-08-08

76259 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

76259

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2002-08-08

Regulatory Status

Discontinued

-
Unclassified Application: 208157

Drug Name

MYXREDLIN

Product Number

1

Dosage Form

-

Strength

100 UNITS/100ML (1 UNIT/ML)

Approval Date

-

208157 / 1

Active Ingredient

INSULIN HUMAN

Application Number

208157

Product Number

1

Dosage Form

-

Strength

100 UNITS/100ML (1 UNIT/ML)

Approval Date

-

Regulatory Status

Unclassified

1989
31 Oct
Discontinued Application: 50655

Drug Name

NALLPEN IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1989-10-31

50655 / 1

Active Ingredient

NAFCILLIN SODIUM

Application Number

50655

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/ML

Approval Date

1989-10-31

Regulatory Status

Discontinued

1989
31 Oct
RX Application: 50655

Drug Name

NALLPEN IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/100ML

Approval Date

1989-10-31

50655 / 2

Active Ingredient

NAFCILLIN SODIUM

Application Number

50655

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/100ML

Approval Date

1989-10-31

Regulatory Status

RX

2021
29 Jan
RX Application: 214785

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2021-01-29

214785 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

214785

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2021-01-29

Regulatory Status

RX

2025
03 Jun
RX Application: 214785

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

2025-06-03

214785 / 2

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

214785

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

2025-06-03

Regulatory Status

RX

2022
07 Nov
RX Application: 214792

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2022-11-07

214792 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

214792

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2022-11-07

Regulatory Status

RX

2008
24 Dec
Discontinued Application: 22325

Drug Name

NEXTERONE

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-24

22325 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

22325

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-24

Regulatory Status

Discontinued

2010
16 Nov
RX Application: 22325

Drug Name

NEXTERONE

Product Number

2

Dosage Form

-

Strength

150MG/100ML (1.5MG/ML)

Approval Date

2010-11-16

22325 / 2

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

22325

Product Number

2

Dosage Form

-

Strength

150MG/100ML (1.5MG/ML)

Approval Date

2010-11-16

Regulatory Status

RX

2010
16 Nov
RX Application: 22325

Drug Name

NEXTERONE

Product Number

3

Dosage Form

-

Strength

360MG/200ML (1.8MG/ML)

Approval Date

2010-11-16

22325 / 3

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

22325

Product Number

3

Dosage Form

-

Strength

360MG/200ML (1.8MG/ML)

Approval Date

2010-11-16

Regulatory Status

RX

1989
29 Dec
RX Application: 19970

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

10MG/100ML

Approval Date

1989-12-29

19970 / 1

Active Ingredient

NITROGLYCERIN

Application Number

19970

Product Number

1

Dosage Form

-

Strength

10MG/100ML

Approval Date

1989-12-29

Regulatory Status

RX

1989
29 Dec
RX Application: 19970

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

2

Dosage Form

-

Strength

20MG/100ML

Approval Date

1989-12-29

19970 / 2

Active Ingredient

NITROGLYCERIN

Application Number

19970

Product Number

2

Dosage Form

-

Strength

20MG/100ML

Approval Date

1989-12-29

Regulatory Status

RX

1989
29 Dec
RX Application: 19970

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

3

Dosage Form

-

Strength

40MG/100ML

Approval Date

1989-12-29

19970 / 3

Active Ingredient

NITROGLYCERIN

Application Number

19970

Product Number

3

Dosage Form

-

Strength

40MG/100ML

Approval Date

1989-12-29

Regulatory Status

RX

2012
27 Mar
RX Application: 40859

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2012-03-27

40859 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

40859

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2012-03-27

Regulatory Status

RX

2026
06 Feb
RX Application: 214313

Drug Name

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Approval Date

2026-02-06

214313 / 4

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

214313

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Approval Date

2026-02-06

Regulatory Status

RX

2026
06 Feb
RX Application: 214313

Drug Name

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)

Approval Date

2026-02-06

214313 / 5

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

214313

Product Number

5

Dosage Form

-

Strength

EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)

Approval Date

2026-02-06

Regulatory Status

RX

2026
06 Feb
RX Application: 214313

Drug Name

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

Approval Date

2026-02-06

214313 / 6

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

214313

Product Number

6

Dosage Form

-

Strength

EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

Approval Date

2026-02-06

Regulatory Status

RX

2021
15 Jan
RX Application: 214313

Drug Name

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Approval Date

2021-01-15

214313 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

214313

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Approval Date

2021-01-15

Regulatory Status

RX

2021
15 Jan
RX Application: 214313

Drug Name

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)

Approval Date

2021-01-15

214313 / 2

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

214313

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)

Approval Date

2021-01-15

Regulatory Status

RX

2023
21 Nov
RX Application: 214313

Drug Name

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Product Number

3

Dosage Form

-

Strength

EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

Approval Date

2023-11-21

214313 / 3

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

214313

Product Number

3

Dosage Form

-

Strength

EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

Approval Date

2023-11-21

Regulatory Status

RX

2019
13 Dec
Discontinued Application: 212535

Drug Name

NOURESS

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2019-12-13

212535 / 1

Active Ingredient

CYSTEINE HYDROCHLORIDE

Application Number

212535

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2019-12-13

Regulatory Status

Discontinued

1993
05 Feb
Discontinued Application: 20107

Drug Name

NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

15% (15GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-02-05

20107 / 1

Active Ingredient

AMINO ACIDS

Application Number

20107

Product Number

1

Dosage Form

-

Strength

15% (15GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-02-05

Regulatory Status

Discontinued

2013
22 Feb
Discontinued Application: 78288

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2013-02-22

78288 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

78288

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2013-02-22

Regulatory Status

Discontinued

2013
22 Feb
RX Application: 78287

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2013-02-22

78287 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

78287

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2013-02-22

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 10% IN WATER

Product Number

2

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

13684 / 2

Active Ingredient

MANNITOL

Application Number

13684

Product Number

2

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

13684 / 6

Active Ingredient

MANNITOL

Application Number

13684

Product Number

6

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 15% IN WATER

Product Number

4

Dosage Form

-

Strength

15GM/100ML

Approval Date

1982-01-01

13684 / 4

Active Ingredient

MANNITOL

Application Number

13684

Product Number

4

Dosage Form

-

Strength

15GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 15% IN WATER IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

15GM/100ML

Approval Date

1982-01-01

13684 / 8

Active Ingredient

MANNITOL

Application Number

13684

Product Number

8

Dosage Form

-

Strength

15GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 20% IN WATER

Product Number

3

Dosage Form

-

Strength

20GM/100ML

Approval Date

1982-01-01

13684 / 3

Active Ingredient

MANNITOL

Application Number

13684

Product Number

3

Dosage Form

-

Strength

20GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 20% IN WATER IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

20GM/100ML

Approval Date

1982-01-01

13684 / 7

Active Ingredient

MANNITOL

Application Number

13684

Product Number

7

Dosage Form

-

Strength

20GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 5% IN WATER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

13684 / 1

Active Ingredient

MANNITOL

Application Number

13684

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 13684

Drug Name

OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

13684 / 5

Active Ingredient

MANNITOL

Application Number

13684

Product Number

5

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

2021
12 Nov
Discontinued Application: 206916

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2021-11-12

206916 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

206916

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2021-11-12

Regulatory Status

Discontinued

2024
14 Feb
RX Application: 217512

Drug Name

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)

Approval Date

2024-02-14

217512 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217512

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)

Approval Date

2024-02-14

Regulatory Status

RX

2024
14 Feb
RX Application: 217512

Drug Name

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)

Approval Date

2024-02-14

217512 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217512

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)

Approval Date

2024-02-14

Regulatory Status

RX

2024
14 Feb
RX Application: 217512

Drug Name

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)

Approval Date

2024-02-14

217512 / 3

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217512

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)

Approval Date

2024-02-14

Regulatory Status

RX

2022
18 Aug
Discontinued Application: 214436

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-08-18

214436 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

214436

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-08-18

Regulatory Status

Discontinued

2022
18 Aug
Discontinued Application: 214436

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-08-18

214436 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

214436

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-08-18

Regulatory Status

Discontinued

1990
25 Jun
RX Application: 50638

Drug Name

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1990-06-25

50638 / 1

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

50638

Product Number

1

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1990-06-25

Regulatory Status

RX

1990
25 Jun
RX Application: 50638

Drug Name

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

40,000 UNITS/ML

Approval Date

1990-06-25

50638 / 2

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

50638

Product Number

2

Dosage Form

-

Strength

40,000 UNITS/ML

Approval Date

1990-06-25

Regulatory Status

RX

1990
25 Jun
RX Application: 50638

Drug Name

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

60,000 UNITS/ML

Approval Date

1990-06-25

50638 / 3

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

50638

Product Number

3

Dosage Form

-

Strength

60,000 UNITS/ML

Approval Date

1990-06-25

Regulatory Status

RX

1995
18 Dec
Discontinued Application: 73617

Drug Name

PENTAMIDINE ISETHIONATE

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1995-12-18

73617 / 1

Active Ingredient

PENTAMIDINE ISETHIONATE

Application Number

73617

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1995-12-18

Regulatory Status

Discontinued

2026
03 Apr
RX Application: 217032

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2026-04-03

217032 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

217032

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2026-04-03

Regulatory Status

RX

2026
03 Apr
RX Application: 217032

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2026-04-03

217032 / 2

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

217032

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2026-04-03

Regulatory Status

RX

2026
03 Apr
RX Application: 217032

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2026-04-03

217032 / 3

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

217032

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2026-04-03

Regulatory Status

RX

2026
26 Feb
RX Application: 216852

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

2026-02-26

216852 / 1

Active Ingredient

PHYTONADIONE

Application Number

216852

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

2026-02-26

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17451

Drug Name

PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML

Approval Date

1982-01-01

17451 / 1

Active Ingredient

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

Application Number

17451

Product Number

1

Dosage Form

-

Strength

5GM/100ML;30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17378

Drug Name

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17378 / 1

Active Ingredient

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

Application Number

17378

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17385

Drug Name

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;32MG/100ML;128MG/100ML;234MG/100ML

Approval Date

1982-01-01

17385 / 1

Active Ingredient

DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Application Number

17385

Product Number

1

Dosage Form

-

Strength

5GM/100ML;32MG/100ML;128MG/100ML;234MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
15 Jun
Discontinued Application: 19047

Drug Name

PLASMA-LYTE 56 IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

32MG/100ML;128MG/100ML;234MG/100ML

Approval Date

1984-06-15

19047 / 1

Active Ingredient

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Application Number

19047

Product Number

1

Dosage Form

-

Strength

32MG/100ML;128MG/100ML;234MG/100ML

Approval Date

1984-06-15

Regulatory Status

Discontinued

1982
22 Nov
RX Application: 17378

Drug Name

PLASMA-LYTE A IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-11-22

17378 / 2

Active Ingredient

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

Application Number

17378

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-11-22

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17390

Drug Name

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

37MG/100ML;5GM/100ML;30MG/100ML;119MG/100ML;161MG/100ML;94MG/100ML;138MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17390 / 1

Active Ingredient

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE

Application Number

17390

Product Number

1

Dosage Form

-

Strength

37MG/100ML;5GM/100ML;30MG/100ML;119MG/100ML;161MG/100ML;94MG/100ML;138MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17438

Drug Name

PLASMA-LYTE R IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;640MG/100ML;496MG/100ML;89.6MG/100ML

Approval Date

1982-01-01

17438 / 1

Active Ingredient

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

Application Number

17438

Product Number

1

Dosage Form

-

Strength

36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;640MG/100ML;496MG/100ML;89.6MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 74812

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

-

74812 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

74812

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 80203

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

80203 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

80203

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85499

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

85499 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

85499

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
26 Nov
RX Application: 17648

Drug Name

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%

Product Number

5

Dosage Form

-

Strength

150MG/100ML;450MG/100ML

Approval Date

2002-11-26

17648 / 5

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

17648

Product Number

5

Dosage Form

-

Strength

150MG/100ML;450MG/100ML

Approval Date

2002-11-26

Regulatory Status

RX

1982
01 Jan
RX Application: 17648

Drug Name

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

150MG/100ML;900MG/100ML

Approval Date

1982-01-01

17648 / 1

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

17648

Product Number

1

Dosage Form

-

Strength

150MG/100ML;900MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17648

Drug Name

POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%

Product Number

3

Dosage Form

-

Strength

224MG/100ML;900MG/100ML

Approval Date

1982-01-01

17648 / 3

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

17648

Product Number

3

Dosage Form

-

Strength

224MG/100ML;900MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17648

Drug Name

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

300MG/100ML;900MG/100ML

Approval Date

1982-01-01

17648 / 2

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

17648

Product Number

2

Dosage Form

-

Strength

300MG/100ML;900MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 2

Active Ingredient

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

Application Number

19367

Product Number

2

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 3

Active Ingredient

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

Application Number

19367

Product Number

3

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1982
28 Apr
RX Application: 18008

Drug Name

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

Product Number

5

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;450MG/100ML

Approval Date

1982-04-28

18008 / 5

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

5

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;450MG/100ML

Approval Date

1982-04-28

Regulatory Status

RX

1982
28 Apr
RX Application: 18008

Drug Name

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

Product Number

6

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;450MG/100ML

Approval Date

1982-04-28

18008 / 6

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

6

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;450MG/100ML

Approval Date

1982-04-28

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 2

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

2

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 4

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

4

Dosage Form

-

Strength

5GM/100ML;75MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1989
26 Dec
RX Application: 19904

Drug Name

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

14.9MG/ML

Approval Date

1989-12-26

19904 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19904

Product Number

1

Dosage Form

-

Strength

14.9MG/ML

Approval Date

1989-12-26

Regulatory Status

RX

1990
17 Dec
RX Application: 19904

Drug Name

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

746MG/100ML

Approval Date

1990-12-17

19904 / 5

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19904

Product Number

5

Dosage Form

-

Strength

746MG/100ML

Approval Date

1990-12-17

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 6

Active Ingredient

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

Application Number

19367

Product Number

6

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 4

Active Ingredient

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

Application Number

19367

Product Number

4

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 5

Active Ingredient

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

Application Number

19367

Product Number

5

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1982
28 Apr
RX Application: 18008

Drug Name

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

Product Number

7

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;450MG/100ML

Approval Date

1982-04-28

18008 / 7

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

7

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;450MG/100ML

Approval Date

1982-04-28

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

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

Product Number

3

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 3

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

3

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

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

Product Number

5

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 5

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

5

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1989
26 Dec
RX Application: 19904

Drug Name

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

29.8MG/ML

Approval Date

1989-12-26

19904 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19904

Product Number

2

Dosage Form

-

Strength

29.8MG/ML

Approval Date

1989-12-26

Regulatory Status

RX

1990
17 Dec
RX Application: 19904

Drug Name

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

1.49GM/100ML

Approval Date

1990-12-17

19904 / 6

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19904

Product Number

6

Dosage Form

-

Strength

1.49GM/100ML

Approval Date

1990-12-17

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 7

Active Ingredient

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

Application Number

19367

Product Number

7

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1982
28 Apr
RX Application: 18008

Drug Name

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

Product Number

8

Dosage Form

-

Strength

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

Approval Date

1982-04-28

18008 / 8

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

8

Dosage Form

-

Strength

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

Approval Date

1982-04-28

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 6

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

6

Dosage Form

-

Strength

5GM/100ML;224MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1989
26 Dec
Discontinued Application: 19904

Drug Name

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2.24GM/100ML

Approval Date

1989-12-26

19904 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19904

Product Number

3

Dosage Form

-

Strength

2.24GM/100ML

Approval Date

1989-12-26

Regulatory Status

Discontinued

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 8

Active Ingredient

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

Application Number

19367

Product Number

8

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1982
28 Apr
RX Application: 18008

Drug Name

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

Product Number

9

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;450MG/100ML

Approval Date

1982-04-28

18008 / 9

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

9

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;450MG/100ML

Approval Date

1982-04-28

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

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

Product Number

7

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 7

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

7

Dosage Form

-

Strength

5GM/100ML;300MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1989
26 Dec
RX Application: 19904

Drug Name

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

2.98GM/100ML

Approval Date

1989-12-26

19904 / 4

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19904

Product Number

4

Dosage Form

-

Strength

2.98GM/100ML

Approval Date

1989-12-26

Regulatory Status

RX

1985
05 Apr
RX Application: 19367

Drug Name

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

19367 / 1

Active Ingredient

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

Application Number

19367

Product Number

1

Dosage Form

-

Strength

20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

1982
01 Jan
RX Application: 18008

Drug Name

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;450MG/100ML

Approval Date

1982-01-01

18008 / 4

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18008

Product Number

4

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1985
05 Apr
RX Application: 19308

Drug Name

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;900MG/100ML

Approval Date

1985-04-05

19308 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

19308

Product Number

1

Dosage Form

-

Strength

5GM/100ML;150MG/100ML;900MG/100ML

Approval Date

1985-04-05

Regulatory Status

RX

2003
19 Jun
RX Application: 75880

Drug Name

PREMASOL 10% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

10% (10GM/100ML)

Approval Date

2003-06-19

75880 / 2

Active Ingredient

AMINO ACIDS

Application Number

75880

Product Number

2

Dosage Form

-

Strength

10% (10GM/100ML)

Approval Date

2003-06-19

Regulatory Status

RX

2003
19 Jun
RX Application: 75880

Drug Name

PREMASOL 6% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

6% (6GM/100ML)

Approval Date

2003-06-19

75880 / 1

Active Ingredient

AMINO ACIDS

Application Number

75880

Product Number

1

Dosage Form

-

Strength

6% (6GM/100ML)

Approval Date

2003-06-19

Regulatory Status

RX

1982
01 Oct
Discontinued Application: 87759

Drug Name

PROCHLORPERAZINE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1982-10-01

87759 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

87759

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1982-10-01

Regulatory Status

Discontinued

-
Unclassified Application: 74719

Drug Name

PROPOFOL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

-

74719 / 1

Active Ingredient

PROPOFOL

Application Number

74719

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 75040

Drug Name

PROPOFOL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

-

75040 / 1

Active Ingredient

PROPOFOL

Application Number

75040

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 16419

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16419 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

16419

Product Number

1

Dosage Form

-

Strength

1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
26 Aug
RX Application: 20849

Drug Name

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

20% (20GM/100ML)

Approval Date

1998-08-26

20849 / 1

Active Ingredient

AMINO ACIDS

Application Number

20849

Product Number

1

Dosage Form

-

Strength

20% (20GM/100ML)

Approval Date

1998-08-26

Regulatory Status

RX

1982
01 Jan
RX Application: 14134

Drug Name

PROTOPAM CHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1982-01-01

14134 / 1

Active Ingredient

PRALIDOXIME CHLORIDE

Application Number

14134

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

1982
13 Dec
Discontinued Application: 18799

Drug Name

PROTOPAM CHLORIDE

Product Number

1

Dosage Form

-

Strength

300MG/ML

Approval Date

1982-12-13

18799 / 1

Active Ingredient

PRALIDOXIME CHLORIDE

Application Number

18799

Product Number

1

Dosage Form

-

Strength

300MG/ML

Approval Date

1982-12-13

Regulatory Status

Discontinued

2023
23 May
RX Application: 217455

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2023-05-23

217455 / 1

Active Ingredient

REGADENOSON

Application Number

217455

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2023-05-23

Regulatory Status

RX

1982
15 Oct
Discontinued Application: 17493

Drug Name

RENAMIN W/O ELECTROLYTES

Product Number

7

Dosage Form

-

Strength

6.5% (6.5GM/100ML)

Approval Date

1982-10-15

17493 / 7

Active Ingredient

AMINO ACIDS

Application Number

17493

Product Number

7

Dosage Form

-

Strength

6.5% (6.5GM/100ML)

Approval Date

1982-10-15

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 16693

Drug Name

RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

33MG/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-01-01

16693 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

16693

Product Number

1

Dosage Form

-

Strength

33MG/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
19 Feb
RX Application: 18495

Drug Name

RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

33MG/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-02-19

18495 / 1

Active Ingredient

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18495

Product Number

1

Dosage Form

-

Strength

33MG/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-02-19

Regulatory Status

RX

2002
02 Jul
RX Application: 75895

Drug Name

SEVOFLURANE

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2002-07-02

75895 / 1

Active Ingredient

SEVOFLURANE

Application Number

75895

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2002-07-02

Regulatory Status

RX

-
Unclassified Application: 218524

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

150MEQ/1000ML (0.150MEQ/ML)

Approval Date

-

218524 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

218524

Product Number

1

Dosage Form

-

Strength

150MEQ/1000ML (0.150MEQ/ML)

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 17864

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

17864 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

17864

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 18016

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

18016 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18016

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
19 Feb
Discontinued Application: 18497

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-02-19

18497 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18497

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-02-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17648

Drug Name

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%

Product Number

4

Dosage Form

-

Strength

75MG/100ML;900MG/100ML

Approval Date

1982-01-01

17648 / 4

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

17648

Product Number

4

Dosage Form

-

Strength

75MG/100ML;900MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 16677

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1982-01-01

16677 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

16677

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16677

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1982-01-01

16677 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

16677

Product Number

3

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1982-01-01

Regulatory Status

RX

1985
30 Oct
RX Application: 16677

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

225MG/25ML (9MG/ML)

Approval Date

1985-10-30

16677 / 4

Active Ingredient

SODIUM CHLORIDE

Application Number

16677

Product Number

4

Dosage Form

-

Strength

225MG/25ML (9MG/ML)

Approval Date

1985-10-30

Regulatory Status

RX

1982
01 Jan
RX Application: 17427

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1982-01-01

17427 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

17427

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17867

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1982-01-01

17867 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

17867

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1992
07 Dec
RX Application: 20178

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1992-12-07

20178 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

20178

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1992-12-07

Regulatory Status

RX

1992
07 Dec
RX Application: 20178

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1992-12-07

20178 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

20178

Product Number

2

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1992-12-07

Regulatory Status

RX

1985
17 May
RX Application: 19319

Drug Name

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-05-17

19319 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

19319

Product Number

2

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-05-17

Regulatory Status

RX

1983
01 Nov
RX Application: 19022

Drug Name

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

1983-11-01

19022 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19022

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

1983-11-01

Regulatory Status

RX

1983
01 Nov
RX Application: 19022

Drug Name

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5GM/100ML

Approval Date

1983-11-01

19022 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

19022

Product Number

2

Dosage Form

-

Strength

5GM/100ML

Approval Date

1983-11-01

Regulatory Status

RX

1988
04 Mar
Discontinued Application: 17036

Drug Name

SODIUM HEPARIN

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1988-03-04

17036 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

17036

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1988-03-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16692

Drug Name

SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1.87GM/100ML

Approval Date

1982-01-01

16692 / 1

Active Ingredient

SODIUM LACTATE

Application Number

16692

Product Number

1

Dosage Form

-

Strength

1.87GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
28 Jul
Discontinued Application: 18581

Drug Name

SODIUM NITROPRUSSIDE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-07-28

18581 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

18581

Product Number

1

Dosage Form

-

Strength

50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-07-28

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17863

Drug Name

SORBITOL 3% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

1982-01-01

17863 / 1

Active Ingredient

SORBITOL

Application Number

17863

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
27 May
Discontinued Application: 18512

Drug Name

SORBITOL 3% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

1982-05-27

18512 / 1

Active Ingredient

SORBITOL

Application Number

18512

Product Number

1

Dosage Form

-

Strength

3GM/100ML

Approval Date

1982-05-27

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17428

Drug Name

STERILE WATER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-01-01

17428 / 1

Active Ingredient

STERILE WATER FOR IRRIGATION

Application Number

17428

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-01-01

Regulatory Status

RX

1982
30 Jun
RX Application: 18632

Drug Name

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-06-30

18632 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18632

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-06-30

Regulatory Status

RX

1988
19 Apr
RX Application: 18632

Drug Name

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

100%

Approval Date

1988-04-19

18632 / 2

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18632

Product Number

2

Dosage Form

-

Strength

100%

Approval Date

1988-04-19

Regulatory Status

RX

1982
01 Jan
RX Application: 17866

Drug Name

STERILE WATER IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-01-01

17866 / 1

Active Ingredient

STERILE WATER FOR IRRIGATION

Application Number

17866

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-01-01

Regulatory Status

RX

2024
24 Sep
RX Application: 218878

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2024-09-24

218878 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

218878

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2024-09-24

Regulatory Status

RX

2023
19 Jan
Discontinued Application: 207101

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2023-01-19

207101 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

207101

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2023-01-19

Regulatory Status

Discontinued

1992
18 Sep
RX Application: 20118

Drug Name

SUPRANE

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1992-09-18

20118 / 1

Active Ingredient

DESFLURANE

Application Number

20118

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1992-09-18

Regulatory Status

RX

1985
25 Jan
Discontinued Application: 19326

Drug Name

SYNOVALYTE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-01-25

19326 / 1

Active Ingredient

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

Application Number

19326

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-01-25

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

40MG/100ML

Approval Date

1982-07-26

18649 / 1

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

1

Dosage Form

-

Strength

40MG/100ML

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1982-07-26

18649 / 2

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1982-07-26

18649 / 3

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-07-26

18649 / 4

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

4

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-07-26

18649 / 5

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

5

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-07-26

Regulatory Status

Discontinued

1985
13 Nov
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

320MG/100ML

Approval Date

1985-11-13

18649 / 6

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

6

Dosage Form

-

Strength

320MG/100ML

Approval Date

1985-11-13

Regulatory Status

Discontinued

1982
26 Jul
Discontinued Application: 18649

Drug Name

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

4MG/ML

Approval Date

1982-07-26

18649 / 7

Active Ingredient

THEOPHYLLINE

Application Number

18649

Product Number

7

Dosage Form

-

Strength

4MG/ML

Approval Date

1982-07-26

Regulatory Status

Discontinued

1982
19 Feb
RX Application: 18508

Drug Name

TIS-U-SOL

Product Number

1

Dosage Form

-

Strength

20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML

Approval Date

1982-02-19

18508 / 1

Active Ingredient

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

Application Number

18508

Product Number

1

Dosage Form

-

Strength

20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML

Approval Date

1982-02-19

Regulatory Status

RX

1982
01 Jan
RX Application: 18336

Drug Name

TIS-U-SOL IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML

Approval Date

1982-01-01

18336 / 1

Active Ingredient

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

Application Number

18336

Product Number

1

Dosage Form

-

Strength

20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML

Approval Date

1982-01-01

Regulatory Status

RX

2016
01 Jul
RX Application: 206965

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2016-07-01

206965 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

206965

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2016-07-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17874

Drug Name

TRANSDERM SCOP

Product Number

1

Dosage Form

-

Strength

1MG/72HR

Approval Date

1982-01-01

17874 / 1

Active Ingredient

SCOPOLAMINE

Application Number

17874

Product Number

1

Dosage Form

-

Strength

1MG/72HR

Approval Date

1982-01-01

Regulatory Status

RX

1982
26 Feb
Discontinued Application: 18660

Drug Name

TRAVAMULSION 10%

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-02-26

18660 / 1

Active Ingredient

SOYBEAN OIL

Application Number

18660

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-02-26

Regulatory Status

Discontinued

1983
15 Feb
Discontinued Application: 18758

Drug Name

TRAVAMULSION 20%

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1983-02-15

18758 / 1

Active Ingredient

SOYBEAN OIL

Application Number

18758

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1983-02-15

Regulatory Status

Discontinued

1984
23 Aug
RX Application: 18931

Drug Name

TRAVASOL 10% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

10% (10MG/100ML)

Approval Date

1984-08-23

18931 / 3

Active Ingredient

AMINO ACIDS

Application Number

18931

Product Number

3

Dosage Form

-

Strength

10% (10MG/100ML)

Approval Date

1984-08-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17493

Drug Name

TRAVASOL 10% W/O ELECTROLYTES

Product Number

6

Dosage Form

-

Strength

10% (10GM/100ML)

Approval Date

1982-01-01

17493 / 6

Active Ingredient

AMINO ACIDS

Application Number

17493

Product Number

6

Dosage Form

-

Strength

10% (10GM/100ML)

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2.75%;10GM/100ML

Approval Date

1988-09-23

19520 / 2

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

2

Dosage Form

-

Strength

2.75%;10GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2.75%;15GM/100ML

Approval Date

1988-09-23

19520 / 3

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

3

Dosage Form

-

Strength

2.75%;15GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

2.75%;20GM/100ML

Approval Date

1988-09-23

19520 / 4

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

4

Dosage Form

-

Strength

2.75%;20GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

2.75%;25GM/100ML

Approval Date

1988-09-23

19520 / 5

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

5

Dosage Form

-

Strength

2.75%;25GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.75%;5GM/100ML

Approval Date

1988-09-23

19520 / 1

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

1

Dosage Form

-

Strength

2.75%;5GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2.75%;10GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

20147 / 2

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

2

Dosage Form

-

Strength

2.75%;10GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2.75%;15GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

20147 / 3

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

3

Dosage Form

-

Strength

2.75%;15GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

2.75%;20GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

20147 / 4

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

4

Dosage Form

-

Strength

2.75%;20GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

2.75%;25GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

20147 / 5

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

5

Dosage Form

-

Strength

2.75%;25GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.75%;5GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

20147 / 1

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

1

Dosage Form

-

Strength

2.75%;5GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20177

Drug Name

TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML

Approval Date

1995-10-23

20177 / 1

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20177

Product Number

1

Dosage Form

-

Strength

3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17493

Drug Name

TRAVASOL 3.5% W/ ELECTROLYTES

Product Number

3

Dosage Form

-

Strength

3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML

Approval Date

1982-01-01

17493 / 3

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

17493

Product Number

3

Dosage Form

-

Strength

3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

4.25%;10GM/100ML

Approval Date

1988-09-23

19520 / 7

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

7

Dosage Form

-

Strength

4.25%;10GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

4.25%;15GM/100ML

Approval Date

1988-09-23

19520 / 8

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

8

Dosage Form

-

Strength

4.25%;15GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

4.25%;20GM/100ML

Approval Date

1988-09-23

19520 / 9

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

9

Dosage Form

-

Strength

4.25%;20GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

4.25%;25GM/100ML

Approval Date

1988-09-23

19520 / 10

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

10

Dosage Form

-

Strength

4.25%;25GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1988
23 Sep
Discontinued Application: 19520

Drug Name

TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

4.25%;5GM/100ML

Approval Date

1988-09-23

19520 / 6

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19520

Product Number

6

Dosage Form

-

Strength

4.25%;5GM/100ML

Approval Date

1988-09-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

4.25%;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

20147 / 7

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

7

Dosage Form

-

Strength

4.25%;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

4.25%;15GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

20147 / 8

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

8

Dosage Form

-

Strength

4.25%;15GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

4.25%;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

20147 / 9

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

9

Dosage Form

-

Strength

4.25%;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

4.25%;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

20147 / 10

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

10

Dosage Form

-

Strength

4.25%;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1995
23 Oct
Discontinued Application: 20147

Drug Name

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

4.25%;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

20147 / 6

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20147

Product Number

6

Dosage Form

-

Strength

4.25%;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML

Approval Date

1995-10-23

Regulatory Status

Discontinued

1984
23 Aug
RX Application: 18931

Drug Name

TRAVASOL 5.5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5.5% (5.5GM/100ML)

Approval Date

1984-08-23

18931 / 1

Active Ingredient

AMINO ACIDS

Application Number

18931

Product Number

1

Dosage Form

-

Strength

5.5% (5.5GM/100ML)

Approval Date

1984-08-23

Regulatory Status

RX

1995
27 Oct
Discontinued Application: 20173

Drug Name

TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML

Approval Date

1995-10-27

20173 / 1

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20173

Product Number

1

Dosage Form

-

Strength

5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML

Approval Date

1995-10-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17493

Drug Name

TRAVASOL 5.5% W/ ELECTROLYTES

Product Number

1

Dosage Form

-

Strength

5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML

Approval Date

1982-01-01

17493 / 1

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

17493

Product Number

1

Dosage Form

-

Strength

5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17493

Drug Name

TRAVASOL 5.5% W/O ELECTROLYTES

Product Number

4

Dosage Form

-

Strength

5.5% (5.5GM/100ML)

Approval Date

1982-01-01

17493 / 4

Active Ingredient

AMINO ACIDS

Application Number

17493

Product Number

4

Dosage Form

-

Strength

5.5% (5.5GM/100ML)

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
23 Aug
RX Application: 18931

Drug Name

TRAVASOL 8.5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

8.5% (8.5GM/100ML)

Approval Date

1984-08-23

18931 / 2

Active Ingredient

AMINO ACIDS

Application Number

18931

Product Number

2

Dosage Form

-

Strength

8.5% (8.5GM/100ML)

Approval Date

1984-08-23

Regulatory Status

RX

1995
27 Oct
Discontinued Application: 20173

Drug Name

TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML

Approval Date

1995-10-27

20173 / 2

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

20173

Product Number

2

Dosage Form

-

Strength

8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML

Approval Date

1995-10-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17493

Drug Name

TRAVASOL 8.5% W/ ELECTROLYTES

Product Number

2

Dosage Form

-

Strength

8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML

Approval Date

1982-01-01

17493 / 2

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

17493

Product Number

2

Dosage Form

-

Strength

8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17493

Drug Name

TRAVASOL 8.5% W/O ELECTROLYTES

Product Number

5

Dosage Form

-

Strength

8.5% (8.5GM/100ML)

Approval Date

1982-01-01

17493 / 5

Active Ingredient

AMINO ACIDS

Application Number

17493

Product Number

5

Dosage Form

-

Strength

8.5% (8.5GM/100ML)

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16717

Drug Name

TRAVERT 10% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

16717 / 1

Active Ingredient

INVERT SUGAR

Application Number

16717

Product Number

1

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
29 Apr
RX Application: 50671

Drug Name

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-04-29

50671 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50671

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-04-29

Regulatory Status

RX

2010
20 Dec
RX Application: 50671

Drug Name

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2010-12-20

50671 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50671

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2010-12-20

Regulatory Status

RX

1999
01 Mar
RX Application: 50671

Drug Name

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

Approval Date

1999-03-01

50671 / 3

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50671

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

Approval Date

1999-03-01

Regulatory Status

RX

2024
25 Jan
RX Application: 50671

Drug Name

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)

Approval Date

2024-01-25

50671 / 4

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50671

Product Number

4

Dosage Form

-

Strength

EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)

Approval Date

2024-01-25

Regulatory Status

RX

2024
25 Jan
RX Application: 50671

Drug Name

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)

Approval Date

2024-01-25

50671 / 5

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

50671

Product Number

5

Dosage Form

-

Strength

EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)

Approval Date

2024-01-25

Regulatory Status

RX

2023
29 Sep
RX Application: 217569

Drug Name

VASOPRESSIN IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

20UNITS/100ML (0.2UNITS/ML)

Approval Date

2023-09-29

217569 / 1

Active Ingredient

VASOPRESSIN

Application Number

217569

Product Number

1

Dosage Form

-

Strength

20UNITS/100ML (0.2UNITS/ML)

Approval Date

2023-09-29

Regulatory Status

RX

2023
29 Sep
RX Application: 217569

Drug Name

VASOPRESSIN IN SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

40UNITS/100ML (0.4UNITS/ML)

Approval Date

2023-09-29

217569 / 2

Active Ingredient

VASOPRESSIN

Application Number

217569

Product Number

2

Dosage Form

-

Strength

40UNITS/100ML (0.4UNITS/ML)

Approval Date

2023-09-29

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 8248

Drug Name

WYAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/ML

Approval Date

1982-01-01

8248 / 1

Active Ingredient

MEPHENTERMINE SULFATE

Application Number

8248

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8248

Drug Name

WYAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

1982-01-01

8248 / 2

Active Ingredient

MEPHENTERMINE SULFATE

Application Number

8248

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
24 Feb
RX Application: 50750

Drug Name

ZOSYN IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML;EQ 5MG BASE/ML

Approval Date

1998-02-24

50750 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50750

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML;EQ 5MG BASE/ML

Approval Date

1998-02-24

Regulatory Status

RX

1998
24 Feb
RX Application: 50750

Drug Name

ZOSYN IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE/ML;EQ 7.5MG BASE/ML

Approval Date

1998-02-24

50750 / 2

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50750

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE/ML;EQ 7.5MG BASE/ML

Approval Date

1998-02-24

Regulatory Status

RX

1998
24 Feb
RX Application: 50750

Drug Name

ZOSYN IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/100ML;EQ 500MG BASE/100ML

Approval Date

1998-02-24

50750 / 3

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

50750

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/100ML;EQ 500MG BASE/100ML

Approval Date

1998-02-24

Regulatory Status

RX

Related Databases
  • FDA Inspections
    169 View
  • EDQM CEP
    1 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    497 View
Drug Status Breakdown
497 total
  • RX
  • Discontinued
  • Unclassified
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETAMINOPHEN

Application Number

214331

Product Number

1

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit