Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074414
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;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
04/30/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074414.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MICONAZOLE NITRATE

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

SUPPOSITORY;VAGINAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 074414 COSETTE
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 073507 P AND L
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 074395 PERRIGO
MONISTAT 7 MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter Yes 018520 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