Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020389
Company: BAYER HEALTHCARE LLC

Products on NDA 020389

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCELEX-7 COMBINATION PACK	CLOTRIMAZOLE	1%,100MG	CREAM, TABLET;TOPICAL, VAGINAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020389

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/1994	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.