Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216942
Company: ENCUBE

Products on ANDA 216942

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 216942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216942

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