Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017619
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LOTRIMIN CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None No No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
03/18/1975 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-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2001 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/2001 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1998 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-29 Labeling

Label is not available on this site.

12/07/2007 SUPPL-28 Efficacy-New Indication

Label is not available on this site.

05/21/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/23/1992 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1990 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-24 Efficacy-New Indication

Label is not available on this site.

10/27/1989 SUPPL-22 Efficacy-Rx To OTC Switch

Label is not available on this site.

10/29/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/18/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-16 Labeling

Label is not available on this site.

07/24/1985 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/03/1984 SUPPL-14 Labeling

Label is not available on this site.

07/03/1984 SUPPL-13 Labeling

Label is not available on this site.

08/18/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1981 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1980 SUPPL-9 Labeling

Label is not available on this site.

01/14/1980 SUPPL-8 Labeling

Label is not available on this site.

05/18/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/16/1978 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1977 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 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1976 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1975 SUPPL-1

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