Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076357
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE 3 COMBINATION PACK MICONAZOLE NITRATE 2%,4% CREAM;TOPICAL, VAGINAL Over-the-counter 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
03/30/2004 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
08/21/2017 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

04/12/2005 SUPPL-5 Labeling

Label is not available on this site.

MICONAZOLE 3 COMBINATION PACK

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

CREAM;TOPICAL, VAGINAL; 2%,4%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE 3 COMBINATION PACK MICONAZOLE NITRATE 2%,4% CREAM;TOPICAL, VAGINAL Over-the-counter No 076357 PERRIGO
MONISTAT 3 COMBINATION PACK MICONAZOLE NITRATE 2%,4% CREAM;TOPICAL, VAGINAL Over-the-counter Yes 021261 MEDTECH PRODUCTS
MONISTAT 3 COMBINATION PACK (PREFILLED) MICONAZOLE NITRATE 2%,4% CREAM;TOPICAL, VAGINAL Over-the-counter Yes 021261 MEDTECH PRODUCTS

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