Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017613
Company: SCHERING PLOUGH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTRIMIN CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;TOPICAL Discontinued None Yes No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
02/03/1975 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1998 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-22 Labeling

Label is not available on this site.

12/07/2007 SUPPL-21 Efficacy-New Indication

Label is not available on this site.

06/23/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1991 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2007 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

04/06/1989 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1989 SUPPL-15 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.

05/20/1985 SUPPL-12 Labeling

Label is not available on this site.

07/03/1984 SUPPL-11 Labeling

Label is not available on this site.

08/06/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1984 SUPPL-9 Labeling

Label is not available on this site.

08/05/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1980 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1978 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/13/1977 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/09/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/13/1977 SUPPL-3 Labeling

Label is not available on this site.

06/29/1976 SUPPL-2 Labeling

Label is not available on this site.

04/22/1975 SUPPL-1 Labeling

Label is not available on this site.

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