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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018181
Company: BAYER HLTHCARE

Products on NDA 018181

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCELEX	CLOTRIMAZOLE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;TOPICAL	Discontinued	None	Yes	No
MYCELEX	CLOTRIMAZOLE	1%	Solution; Topical	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018181

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-11	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
08/29/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
05/13/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/03/1995	SUPPL-8	Labeling		Label is not available on this site.
05/12/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/01/1991	SUPPL-6	Labeling		Label is not available on this site.
03/16/1990	SUPPL-5	Labeling		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

MYCELEX

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

Solution; Topical; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LOTRIMIN AF	CLOTRIMAZOLE	1%	Solution; Topical	Over-the-counter	Yes	020890	SCHERING PLOUGH
MYCELEX	CLOTRIMAZOLE	1%	Solution; Topical	Over-the-counter	No	018181	BAYER HLTHCARE

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