Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075329
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;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
04/20/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-329_Miconazole%20Nitrate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75329ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-329_Miconazole.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2017 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

04/08/2005 SUPPL-15 Labeling

Label is not available on this site.

05/20/2003 SUPPL-9 Labeling

Label is not available on this site.

01/29/2002 SUPPL-2 Labeling

Label is not available on this site.

01/29/2002 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/20/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-329_Miconazole%20Nitrate_prntlbl.pdf

MICONAZOLE NITRATE 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, SUPPOSITORY;TOPICAL, VAGINAL; 2%,200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
M-ZOLE 3 COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter No 074926 P AND L
MICONAZOLE NITRATE COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter No 075329 PERRIGO
MONISTAT 3 COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter Yes 020670 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