Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017717
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GYNE-LOTRIMIN CLOTRIMAZOLE 100MG TABLET;VAGINAL 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
03/24/1976 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1997 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/1992 SUPPL-21 Labeling

Label is not available on this site.

04/14/1992 SUPPL-20 Labeling

Label is not available on this site.

06/23/1992 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1990 SUPPL-16 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.

09/16/1982 SUPPL-12 Labeling

Label is not available on this site.

11/12/1981 SUPPL-11 Labeling

Label is not available on this site.

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

Label is not available on this site.

12/11/1980 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/23/1980 SUPPL-6 Labeling

Label is not available on this site.

07/16/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1979 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/18/1978 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/15/1977 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/09/1977 SUPPL-1 Manufacturing (CMC)

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