Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018181
Company: BAYER HLTHCARE
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MYCELEX CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;TOPICAL Discontinued None Yes No
MYCELEX CLOTRIMAZOLE 1% Solution; Topical Over-the-counter None No No
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.

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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