Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020827
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONISTAT 3 MICONAZOLE NITRATE 4% CREAM;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
03/30/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/28/2020 SUPPL-31 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
03/10/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/27/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/11/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/10/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/29/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/02/2009 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020827s014ltr.pdf
09/05/2008 SUPPL-13 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020827s013ltr.pdf
10/28/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

11/28/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/07/2002 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20827slr006ltr.pdf
03/26/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/30/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/27/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1998 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-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf
10/02/2009 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf
10/02/2009 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020827Orig1s014lbl.pdf
03/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_prntlbl.pdf

MONISTAT 3

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

CREAM;VAGINAL; 4%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE 3 MICONAZOLE NITRATE 4% CREAM;VAGINAL Over-the-counter No 076773 TARO
MICONAZOLE NITRATE MICONAZOLE NITRATE 4% CREAM;VAGINAL Over-the-counter No 091366 PERRIGO R AND D
MONISTAT 3 MICONAZOLE NITRATE 4% CREAM;VAGINAL Over-the-counter Yes 020827 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