Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018230
Company: BAYER HEALTHCARE LLC

Products on NDA 018230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCELEX-7	CLOTRIMAZOLE	1%	CREAM;VAGINAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018230

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/1979	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2001	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
02/10/2000	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
09/01/1998	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/24/1996	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/09/1996	SUPPL-16	Labeling		Label is not available on this site.
02/13/1995	SUPPL-13	Labeling		Label is not available on this site.
10/08/1992	SUPPL-11	Labeling		Label is not available on this site.
02/22/1993	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/26/1991	SUPPL-9	Efficacy-Rx To OTC Switch		Label is not available on this site.
06/14/1990	SUPPL-8	Labeling		Label is not available on this site.
06/03/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/27/1982	SUPPL-5	Labeling		Label is not available on this site.
10/23/1980	SUPPL-3	Labeling		Label is not available on this site.
09/08/1980	SUPPL-2	Labeling		Label is not available on this site.
04/01/1980	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.