Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English