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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018813
Company: SCHERING

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTRIMIN CLOTRIMAZOLE 1% LOTION;TOPICAL Discontinued 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
02/17/1984 ORIG-1 Approval Type 3 - New Dosage Form 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
01/10/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
03/06/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
09/07/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/14/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
05/18/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
12/07/2007 SUPPL-18 Labeling

Label is not available on this site.
12/07/2007 SUPPL-17 Efficacy-New Indication

Label is not available on this site.
07/02/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
02/12/1993 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/23/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
10/25/1991 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/07/2007 SUPPL-12 Labeling

Label is not available on this site.
03/07/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
12/07/2007 SUPPL-10 Efficacy-New Indication

Label is not available on this site.
04/06/1989 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/27/1989 SUPPL-7 Efficacy-Rx To OTC Switch

Label is not available on this site.
06/18/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
05/20/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
05/20/1985 SUPPL-4 Labeling

Label is not available on this site.
04/16/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/06/1984 SUPPL-2 Labeling

Label is not available on this site.
08/06/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.
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