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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020827
Company: MEDTECH PRODUCTS

Products on NDA 020827

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020827

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2021	SUPPL-33	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020827Orig1s033ltr.pdf
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.

Labels for NDA 020827

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

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

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	SUN PHARMA CANADA
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

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