Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077524
Company: DR REDDYS LABS SA

Products on ANDA 077524

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 077524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2008	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077524s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077524_original_approval_pkg.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/29/2014	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077524

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	BAUSCH
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	090368	TARO