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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021308
Company: MEDTECH PRODUCTS

Products on NDA 021308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONISTAT 1 COMBINATION PACK	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT;TOPICAL, VAGINAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021308

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/021308Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21308ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-308_Monistat.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2020	SUPPL-31	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-30	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
02/11/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/13/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/10/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/06/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/04/2005	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021308Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21308s010ltr.pdf
10/01/2004	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021308Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21308s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021308_S009_MONISTAT 1.pdf
12/03/2003	SUPPL-8	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21308scp008ltr.pdf
11/20/2002	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308slr005ltr.pdf
09/06/2002	SUPPL-4	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308scp004ltr.pdf
10/28/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/06/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021308

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2020	SUPPL-31	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf
01/28/2020	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf
04/04/2005	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021308Orig1s010lbl.pdf
10/01/2004	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021308Orig1s009lbl.pdf
06/29/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/021308Orig1s000lbl.pdf

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

MONISTAT 1 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, INSERT;TOPICAL, VAGINAL; 2%,1.2GM

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT;TOPICAL, VAGINAL	Over-the-counter	No	079114	PERRIGO R AND D
MONISTAT 1 COMBINATION PACK	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT;TOPICAL, VAGINAL	Over-the-counter	Yes	021308	MEDTECH PRODUCTS

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