Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076574
Company: ENCUBE

Products on ANDA 076574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076574_ORIGINAL APPROVAL_PACKAGE.pdf