Bristol Laboratories Ltd
FDA Approved Drugs

Bristol Laboratories Ltd

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 83
  • Latest Approval Date Apr 17, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
83
View
Unclassified
3
View
Discontinued
61
View
RX
19
View
Company Overview

Company

Bristol Laboratories Ltd

Country

United Kingdom

Website

Visit Website

Email

info@bristol-labs.co.uk

Social Profiles

Company Snapshot

Bristol Laboratories Ltd

Bristol House, Unit 3, Canalside, Northbridge Road Berkhamsted, Hertfordshire

United Kingdom

bristol-labs.co.uk/ info@bristol-labs.co.uk View on Map
FDA Approved Drug Records ( 83 records )
2023
15 Nov
RX Application: 218213

Drug Name

AUGTYRO

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2023-11-15

218213 / 1

Active Ingredient

REPOTRECTINIB

Application Number

218213

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2023-11-15

Regulatory Status

RX

2024
11 Jun
RX Application: 218213

Drug Name

AUGTYRO

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2024-06-11

218213 / 2

Active Ingredient

REPOTRECTINIB

Application Number

218213

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2024-06-11

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 61150

Drug Name

BETAPEN-VK

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61150 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

61150

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61150

Drug Name

BETAPEN-VK

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61150 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

61150

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61658

Drug Name

BRISTACYCLINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

61658 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61658

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61658

Drug Name

BRISTACYCLINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

61658 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61658

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61888

Drug Name

BRISTACYCLINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

61888 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61888

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61888

Drug Name

BRISTACYCLINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

61888 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

61888

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62288

Drug Name

BRISTAGEN

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1982-01-01

62288 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62288

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61304

Drug Name

BRISTAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61304 / 1

Active Ingredient

ERYTHROMYCIN STEARATE

Application Number

61304

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61887

Drug Name

BRISTAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61887 / 1

Active Ingredient

ERYTHROMYCIN STEARATE

Application Number

61887

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-04-28

214998 / 1

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2022-04-28

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-04-28

214998 / 2

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-04-28

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-04-28

214998 / 3

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-04-28

Regulatory Status

RX

2022
28 Apr
RX Application: 214998

Drug Name

CAMZYOS

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2022-04-28

214998 / 4

Active Ingredient

MAVACAMTEN

Application Number

214998

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2022-04-28

Regulatory Status

RX

1984
07 May
Discontinued Application: 62464

Drug Name

CEPHALOTHIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1984-05-07

62464 / 1

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62464

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1984-05-07

Regulatory Status

Discontinued

1984
07 May
Discontinued Application: 62464

Drug Name

CEPHALOTHIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1984-05-07

62464 / 2

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62464

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1984-05-07

Regulatory Status

Discontinued

1984
07 May
Discontinued Application: 62464

Drug Name

CEPHALOTHIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL

Approval Date

1984-05-07

62464 / 3

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62464

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL

Approval Date

1984-05-07

Regulatory Status

Discontinued

-
Unclassified Application: 220073

Drug Name

ELIQUIS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

220073 / 2

Active Ingredient

APIXABAN

Application Number

220073

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220073

Drug Name

ELIQUIS

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

-

220073 / 3

Active Ingredient

APIXABAN

Application Number

220073

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220073

Drug Name

ELIQUIS

Product Number

4

Dosage Form

-

Strength

0.15MG

Approval Date

-

220073 / 4

Active Ingredient

APIXABAN

Application Number

220073

Product Number

4

Dosage Form

-

Strength

0.15MG

Approval Date

-

Regulatory Status

Unclassified

2025
17 Apr
RX Application: 220073

Drug Name

ELIQUIS SPRINKLE

Product Number

1

Dosage Form

-

Strength

0.15MG

Approval Date

2025-04-17

220073 / 1

Active Ingredient

APIXABAN

Application Number

220073

Product Number

1

Dosage Form

-

Strength

0.15MG

Approval Date

2025-04-17

Regulatory Status

RX

2015
29 Jan
RX Application: 206353

Drug Name

EVOTAZ

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE;150MG

Approval Date

2015-01-29

206353 / 1

Active Ingredient

ATAZANAVIR SULFATE; COBICISTAT

Application Number

206353

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE;150MG

Approval Date

2015-01-29

Regulatory Status

RX

2022
12 Dec
RX Application: 216340

Drug Name

KRAZATI

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-12-12

216340 / 1

Active Ingredient

ADAGRASIB

Application Number

216340

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2022-12-12

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 86358

Drug Name

MEXATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1982-01-01

86358 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

86358

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86358

Drug Name

MEXATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

1982-01-01

86358 / 2

Active Ingredient

METHOTREXATE SODIUM

Application Number

86358

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86358

Drug Name

MEXATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1982-01-01

86358 / 3

Active Ingredient

METHOTREXATE SODIUM

Application Number

86358

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86358

Drug Name

MEXATE

Product Number

4

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

86358 / 4

Active Ingredient

METHOTREXATE SODIUM

Application Number

86358

Product Number

4

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50450

Drug Name

MUTAMYCIN

Product Number

1

Dosage Form

-

Strength

5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50450 / 1

Active Ingredient

MITOMYCIN

Application Number

50450

Product Number

1

Dosage Form

-

Strength

5MG/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: 50450

Drug Name

MUTAMYCIN

Product Number

2

Dosage Form

-

Strength

20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50450 / 2

Active Ingredient

MITOMYCIN

Application Number

50450

Product Number

2

Dosage Form

-

Strength

20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
01 Sep
RX Application: 214120

Drug Name

ONUREG

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2020-09-01

214120 / 1

Active Ingredient

AZACITIDINE

Application Number

214120

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2020-09-01

Regulatory Status

RX

2020
01 Sep
RX Application: 214120

Drug Name

ONUREG

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2020-09-01

214120 / 2

Active Ingredient

AZACITIDINE

Application Number

214120

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2020-09-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 50093

Drug Name

POLYCILLIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1982-01-01

50093 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50093

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50308

Drug Name

POLYCILLIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

50308 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50308

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50308

Drug Name

POLYCILLIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

50308 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50308

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50308

Drug Name

POLYCILLIN

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

50308 / 3

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50308

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50308

Drug Name

POLYCILLIN

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1982-01-01

50308 / 4

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50308

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50310

Drug Name

POLYCILLIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

50310 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50310

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50310

Drug Name

POLYCILLIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

50310 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

50310

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50309

Drug Name

POLYCILLIN-N

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50309 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

50309

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/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: 50309

Drug Name

POLYCILLIN-N

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50309 / 2

Active Ingredient

AMPICILLIN SODIUM

Application Number

50309

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/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: 50309

Drug Name

POLYCILLIN-N

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50309 / 3

Active Ingredient

AMPICILLIN SODIUM

Application Number

50309

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/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: 50309

Drug Name

POLYCILLIN-N

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50309 / 4

Active Ingredient

AMPICILLIN SODIUM

Application Number

50309

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/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: 50309

Drug Name

POLYCILLIN-N

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50309 / 5

Active Ingredient

AMPICILLIN SODIUM

Application Number

50309

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/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: 50457

Drug Name

POLYCILLIN-PRB

Product Number

1

Dosage Form

-

Strength

EQ 3.5GM BASE/BOT;1GM/BOT

Approval Date

1982-01-01

50457 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID

Application Number

50457

Product Number

1

Dosage Form

-

Strength

EQ 3.5GM BASE/BOT;1GM/BOT

Approval Date

1982-01-01

Regulatory Status

Discontinued

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-02-08

204026 / 1

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-02-08

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-02-08

204026 / 2

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-02-08

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2013-02-08

204026 / 3

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2013-02-08

Regulatory Status

RX

2013
08 Feb
RX Application: 204026

Drug Name

POMALYST

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2013-02-08

204026 / 4

Active Ingredient

POMALIDOMIDE

Application Number

204026

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2013-02-08

Regulatory Status

RX

1984
24 May
Discontinued Application: 50554

Drug Name

PRECEF

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1984-05-24

50554 / 1

Active Ingredient

CEFORANIDE

Application Number

50554

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1984-05-24

Regulatory Status

Discontinued

1984
24 May
Discontinued Application: 50554

Drug Name

PRECEF

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1984-05-24

50554 / 2

Active Ingredient

CEFORANIDE

Application Number

50554

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1984-05-24

Regulatory Status

Discontinued

1984
24 May
Discontinued Application: 50554

Drug Name

PRECEF

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1984-05-24

50554 / 3

Active Ingredient

CEFORANIDE

Application Number

50554

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1984-05-24

Regulatory Status

Discontinued

1984
24 May
Discontinued Application: 50554

Drug Name

PRECEF

Product Number

4

Dosage Form

-

Strength

10GM/VIAL

Approval Date

1984-05-24

50554 / 4

Active Ingredient

CEFORANIDE

Application Number

50554

Product Number

4

Dosage Form

-

Strength

10GM/VIAL

Approval Date

1984-05-24

Regulatory Status

Discontinued

1984
24 May
Discontinued Application: 50554

Drug Name

PRECEF

Product Number

5

Dosage Form

-

Strength

20GM/VIAL

Approval Date

1984-05-24

50554 / 5

Active Ingredient

CEFORANIDE

Application Number

50554

Product Number

5

Dosage Form

-

Strength

20GM/VIAL

Approval Date

1984-05-24

Regulatory Status

Discontinued

2022
09 Sep
RX Application: 214958

Drug Name

SOTYKTU

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2022-09-09

214958 / 1

Active Ingredient

DEUCRAVACITINIB

Application Number

214958

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2022-09-09

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 50212

Drug Name

TETREX

Product Number

2

Dosage Form

-

Strength

EQ 250MG HYDROCHLORIDE

Approval Date

1982-01-01

50212 / 2

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

50212

Product Number

2

Dosage Form

-

Strength

EQ 250MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50212

Drug Name

TETREX

Product Number

3

Dosage Form

-

Strength

EQ 500MG HYDROCHLORIDE

Approval Date

1982-01-01

50212 / 3

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

50212

Product Number

3

Dosage Form

-

Strength

EQ 500MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61653

Drug Name

TETREX

Product Number

1

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE

Approval Date

1982-01-01

61653 / 1

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

61653

Product Number

1

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61653

Drug Name

TETREX

Product Number

2

Dosage Form

-

Strength

EQ 250MG HYDROCHLORIDE

Approval Date

1982-01-01

61653 / 2

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

61653

Product Number

2

Dosage Form

-

Strength

EQ 250MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61653

Drug Name

TETREX

Product Number

3

Dosage Form

-

Strength

EQ 500MG HYDROCHLORIDE

Approval Date

1982-01-01

61653 / 3

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

61653

Product Number

3

Dosage Form

-

Strength

EQ 500MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61889

Drug Name

TETREX

Product Number

1

Dosage Form

-

Strength

EQ 500MG HYDROCHLORIDE

Approval Date

1982-01-01

61889 / 1

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

61889

Product Number

1

Dosage Form

-

Strength

EQ 500MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61889

Drug Name

TETREX

Product Number

2

Dosage Form

-

Strength

EQ 250MG HYDROCHLORIDE

Approval Date

1982-01-01

61889 / 2

Active Ingredient

TETRACYCLINE PHOSPHATE COMPLEX

Application Number

61889

Product Number

2

Dosage Form

-

Strength

EQ 250MG HYDROCHLORIDE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
16 Mar
Discontinued Application: 62376

Drug Name

ULTRACEF

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-03-16

62376 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62376

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-03-16

Regulatory Status

Discontinued

1982
16 Mar
Discontinued Application: 62376

Drug Name

ULTRACEF

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-03-16

62376 / 2

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62376

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-03-16

Regulatory Status

Discontinued

1982
16 Mar
Discontinued Application: 62376

Drug Name

ULTRACEF

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-03-16

62376 / 3

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62376

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

1982-03-16

Regulatory Status

Discontinued

1982
16 Mar
Discontinued Application: 62378

Drug Name

ULTRACEF

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-03-16

62378 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62378

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-03-16

Regulatory Status

Discontinued

1982
31 Aug
Discontinued Application: 62408

Drug Name

ULTRACEF

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1982-08-31

62408 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

62408

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1982-08-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50060

Drug Name

VERSAPEN

Product Number

1

Dosage Form

-

Strength

EQ 112.5MG AMPICIL/5ML

Approval Date

1982-01-01

50060 / 1

Active Ingredient

HETACILLIN

Application Number

50060

Product Number

1

Dosage Form

-

Strength

EQ 112.5MG AMPICIL/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50060

Drug Name

VERSAPEN

Product Number

3

Dosage Form

-

Strength

EQ 112.5MG AMPICIL/ML

Approval Date

1982-01-01

50060 / 3

Active Ingredient

HETACILLIN

Application Number

50060

Product Number

3

Dosage Form

-

Strength

EQ 112.5MG AMPICIL/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61398

Drug Name

VERSAPEN

Product Number

1

Dosage Form

-

Strength

EQ 112.5MG AMPICIL/ML

Approval Date

1982-01-01

61398 / 1

Active Ingredient

HETACILLIN

Application Number

61398

Product Number

1

Dosage Form

-

Strength

EQ 112.5MG AMPICIL/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61398

Drug Name

VERSAPEN

Product Number

2

Dosage Form

-

Strength

EQ 225MG AMPICIL/5ML

Approval Date

1982-01-01

61398 / 2

Active Ingredient

HETACILLIN

Application Number

61398

Product Number

2

Dosage Form

-

Strength

EQ 225MG AMPICIL/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61396

Drug Name

VERSAPEN-K

Product Number

1

Dosage Form

-

Strength

EQ 225MG AMPICIL

Approval Date

1982-01-01

61396 / 1

Active Ingredient

HETACILLIN POTASSIUM

Application Number

61396

Product Number

1

Dosage Form

-

Strength

EQ 225MG AMPICIL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61396

Drug Name

VERSAPEN-K

Product Number

2

Dosage Form

-

Strength

EQ 450MG AMPICIL

Approval Date

1982-01-01

61396 / 2

Active Ingredient

HETACILLIN POTASSIUM

Application Number

61396

Product Number

2

Dosage Form

-

Strength

EQ 450MG AMPICIL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
09 Oct
Discontinued Application: 20156

Drug Name

VIDEX

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-10-09

20156 / 1

Active Ingredient

DIDANOSINE

Application Number

20156

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-10-09

Regulatory Status

Discontinued

2020
25 Mar
RX Application: 209899

Drug Name

ZEPOSIA

Product Number

1

Dosage Form

-

Strength

EQ 0.23MG BASE

Approval Date

2020-03-25

209899 / 1

Active Ingredient

OZANIMOD HYDROCHLORIDE

Application Number

209899

Product Number

1

Dosage Form

-

Strength

EQ 0.23MG BASE

Approval Date

2020-03-25

Regulatory Status

RX

2020
25 Mar
RX Application: 209899

Drug Name

ZEPOSIA

Product Number

2

Dosage Form

-

Strength

EQ 0.46MG BASE

Approval Date

2020-03-25

209899 / 2

Active Ingredient

OZANIMOD HYDROCHLORIDE

Application Number

209899

Product Number

2

Dosage Form

-

Strength

EQ 0.46MG BASE

Approval Date

2020-03-25

Regulatory Status

RX

2020
25 Mar
RX Application: 209899

Drug Name

ZEPOSIA

Product Number

3

Dosage Form

-

Strength

EQ 0.92MG BASE

Approval Date

2020-03-25

209899 / 3

Active Ingredient

OZANIMOD HYDROCHLORIDE

Application Number

209899

Product Number

3

Dosage Form

-

Strength

EQ 0.92MG BASE

Approval Date

2020-03-25

Regulatory Status

RX

1994
24 Jun
Discontinued Application: 20412

Drug Name

ZERIT

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1994-06-24

20412 / 1

Active Ingredient

STAVUDINE

Application Number

20412

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1994-06-24

Regulatory Status

Discontinued

1994
24 Jun
Discontinued Application: 20412

Drug Name

ZERIT

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

20412 / 2

Active Ingredient

STAVUDINE

Application Number

20412

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

Regulatory Status

Discontinued

1994
24 Jun
Discontinued Application: 20412

Drug Name

ZERIT

Product Number

3

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

20412 / 3

Active Ingredient

STAVUDINE

Application Number

20412

Product Number

3

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

Regulatory Status

Discontinued

1994
24 Jun
Discontinued Application: 20412

Drug Name

ZERIT

Product Number

4

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

20412 / 4

Active Ingredient

STAVUDINE

Application Number

20412

Product Number

4

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

Regulatory Status

Discontinued

1994
24 Jun
Discontinued Application: 20412

Drug Name

ZERIT

Product Number

5

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

20412 / 5

Active Ingredient

STAVUDINE

Application Number

20412

Product Number

5

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-06-24

Regulatory Status

Discontinued

1996
06 Sep
Discontinued Application: 20413

Drug Name

ZERIT

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

1996-09-06

20413 / 1

Active Ingredient

STAVUDINE

Application Number

20413

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

1996-09-06

Regulatory Status

Discontinued

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Drug Status Breakdown
83 total
  • RX
  • Discontinued
  • Unclassified
Official Source

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

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

Drug Name

AUGTYRO

Application Number

218213

Product Number

1

Active Ingredient

REPOTRECTINIB

Dosage Form

-

Strength

40MG

FDA Approved Drug Data

Approved drug product information

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