Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020670
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONISTAT 3 COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter None Yes 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
04/16/1996 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch 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
01/28/2020 SUPPL-35 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030ltr.pdf
01/21/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/20/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/11/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/10/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/16/2007 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020670s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020670Orig1s014.pdf
01/09/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20670slr011ltr.pdf
10/28/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2002 SUPPL-9 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020670s009Approv.pdf
01/20/2000 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/26/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/21/1997 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/15/1996 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/28/2020 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf
03/16/2007 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf
03/16/2007 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf

MONISTAT 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, 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