Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017494
Company: INSIGHT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONISTAT-DERM MICONAZOLE NITRATE 2% 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
01/08/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
02/11/2014 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

02/11/2014 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/27/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

01/02/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/12/1998 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1990 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1988 SUPPL-24 Labeling

Label is not available on this site.

09/17/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/25/1986 SUPPL-22 Labeling

Label is not available on this site.

06/24/1985 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1985 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/02/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/19/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/13/1981 SUPPL-14 Labeling

Label is not available on this site.

04/28/1980 SUPPL-13 Labeling

Label is not available on this site.

12/16/1976 SUPPL-9 Labeling

Label is not available on this site.

04/21/1977 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/30/1975 SUPPL-5 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