Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020526
Company: BAYER HEALTHCARE LLC

Products on NDA 020526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GYNE-LOTRIMIN 3 COMBINATION PACK	CLOTRIMAZOLE	1%,200MG	CREAM, TABLET;TOPICAL, VAGINAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1996	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	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
01/16/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/1998	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/17/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/27/1997	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.