Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076526
Company: TARO

Products on ANDA 076526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROURACIL	FLUOROURACIL	2%	SOLUTION;TOPICAL	Prescription	AT	No	No
FLUOROURACIL	FLUOROURACIL	5%	SOLUTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2022	SUPPL-8	Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 076526

FLUOROURACIL

SOLUTION;TOPICAL; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFUDEX	FLUOROURACIL	2%	SOLUTION;TOPICAL	Prescription	Yes	AT	016831	BAUSCH
FLUOROURACIL	FLUOROURACIL	2%	SOLUTION;TOPICAL	Prescription	No	AT	076526	TARO

SOLUTION;TOPICAL; 5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOROURACIL	FLUOROURACIL	5%	SOLUTION;TOPICAL	Prescription	No	AT	215612	ENCUBE
FLUOROURACIL	FLUOROURACIL	5%	SOLUTION;TOPICAL	Prescription	No	AT	076526	TARO