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Approved Drug Products containing CAS-51-21-8 listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS LABS SA

02 3TARO

03 1ABIC

04 3ABRAXIS PHARM

05 5ACCORD HLTHCARE

06 2ALEMBIC

07 3BAUSCH

08 1BEDFORD

09 1CHARTWELL RX

10 1EBEWE PHARMA

11 1ELORAC

12 1ENCUBE

13 4EUGIA PHARMA SPECLTS

14 1EXTROVIS

15 6FRESENIUS KABI USA

16 4GLAND PHARMA LTD

17 1HILL DERMACEUTICALS

18 1MARCHAR

19 4NOVAST LABS

20 2PHARMACIA AND UPJOHN

21 2QUAD PHARMS

22 4SAGENT PHARMS INC

23 2SANDOZ

24 3SMITH AND NEPHEW

25 3SPECTRUM PHARMS

26 2TEVA PARENTERAL

27 3TEVA PHARMS USA

28 1VALEANT PHARMS NORTH

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

FLUOROURACIL

Brand Name : FLUOROURACIL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 5%

Approval Date : 2008-04-11

Application Number : 77524

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : FLUOROURACIL

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 2%

Approval Date : 2003-11-05

Application Number : 76526

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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03

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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : FLUOROURACIL

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2003-11-05

Application Number : 76526

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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04

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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : FLUOROURACIL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 5%

Approval Date : 2010-03-05

Application Number : 90368

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : EFUDEX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 2%

Approval Date : 1982-01-01

Application Number : 16831

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : EFUDEX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 16831

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : EFUDEX

Dosage Form : CREAM;TOPICAL

Dosage Strength : 5%

Approval Date : 1982-01-01

Application Number : 16831

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : FLUOROPLEX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1%

Approval Date : 1982-01-01

Application Number : 16765

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : FLUOROURACIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 12209

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

FLUOROURACIL

Brand Name : FLUOROURACIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2016-07-29

Application Number : 12209

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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