Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017717
Company: BAYER HEALTHCARE LLC

Products on NDA 017717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GYNE-LOTRIMIN	CLOTRIMAZOLE	100MG	TABLET;VAGINAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/1976	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/1999	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
03/17/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/27/1997	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/08/1992	SUPPL-21	Labeling		Label is not available on this site.
04/14/1992	SUPPL-20	Labeling		Label is not available on this site.
06/23/1992	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/1990	SUPPL-16	Efficacy-Rx To OTC Switch		Label is not available on this site.
06/18/1987	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1986	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/16/1982	SUPPL-12	Labeling		Label is not available on this site.
11/12/1981	SUPPL-11	Labeling		Label is not available on this site.
08/05/1981	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/1980	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/23/1980	SUPPL-6	Labeling		Label is not available on this site.
07/16/1979	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/23/1979	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/18/1978	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/15/1977	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/09/1977	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.