Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074165
Company: P AND L
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;VAGINAL Over-the-counter None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/1993 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/09/2015 SUPPL-39 Labeling-Container/Carton Labels

Label is not available on this site.

01/05/2015 SUPPL-38 Labeling-Container/Carton Labels

Label is not available on this site.

04/14/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

04/14/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

07/10/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1999 SUPPL-18 Labeling

Label is not available on this site.

11/15/1999 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/15/1999 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/11/1997 SUPPL-12 Labeling

Label is not available on this site.

06/28/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-5 Labeling

Label is not available on this site.

10/19/1994 SUPPL-4 Labeling

Label is not available on this site.

12/10/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/20/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/24/1994 SUPPL-1 Labeling

Label is not available on this site.

CLOTRIMAZOLE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM;VAGINAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;VAGINAL Over-the-counter No 074165 P AND L
CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM;VAGINAL Over-the-counter No 072641 TARO

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