Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018183
Company: BAYER HEALTHCARE LLC

Products on NDA 018183

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/1979	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
08/29/2001	SUPPL-21	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
09/21/2000	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2001	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
08/06/1999	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/06/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/06/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/03/1996	SUPPL-14	Labeling		Label is not available on this site.
04/03/1995	SUPPL-13	Labeling		Label is not available on this site.
05/12/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/29/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/07/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/29/1991	SUPPL-9	Labeling		Label is not available on this site.
04/01/1991	SUPPL-8	Labeling		Label is not available on this site.