Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090368
Company: TARO

Products on ANDA 090368

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROURACIL	FLUOROURACIL	5%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2010	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
01/30/2024	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
11/07/2022	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090368

FLUOROURACIL

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFUDEX	FLUOROURACIL	5%	CREAM;TOPICAL	Prescription	Yes	AB	016831	EXTROVIS
FLUOROURACIL	FLUOROURACIL	5%	CREAM;TOPICAL	Prescription	No	AB	214845	ACCORD HLTHCARE
FLUOROURACIL	FLUOROURACIL	5%	CREAM;TOPICAL	Prescription	No	AB	077524	DR REDDYS LABS SA
FLUOROURACIL	FLUOROURACIL	5%	CREAM;TOPICAL	Prescription	No	AB	216942	ENCUBE
FLUOROURACIL	FLUOROURACIL	5%	CREAM;TOPICAL	Prescription	No	AB	090368	TARO