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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020670
Company: MEDTECH PRODUCTS

Products on NDA 020670

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020670

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
11/17/2023	SUPPL-41	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020670Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020670Orig1s041ltr.pdf
07/22/2020	SUPPL-36	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/17450Orig1s075,20670Orig1s036,21261Orig1s025,21308Orig1s031ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 020670

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2023	SUPPL-41	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020670Orig1s041lbl.pdf
07/22/2020	SUPPL-36	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf
03/16/2007	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020670Orig1s014lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	L PERRIGO CO
MONISTAT 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	Over-the-counter	Yes	020670	MEDTECH PRODUCTS

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