Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021261
Company: MEDTECH PRODUCTS

Products on NDA 21261

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONISTAT 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,4%	CREAM;TOPICAL, VAGINAL	Over-the-counter	None	Yes	No
MONISTAT 3 COMBINATION PACK (PREFILLED)	MICONAZOLE NITRATE	2%,4%	CREAM;TOPICAL, VAGINAL	Over-the-counter	None	Yes	Yes

Labels for NDA 021261

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2020	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s075,020670Orig1s036,021261Orig1s025,021308Orig1s031lbl.pdf
01/28/2020	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017450Orig1s073,020670Orig1s035,020827Orig1s031,021261Orig1s024,021308Orig1s030lbl.pdf
12/21/2009	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf
12/21/2009	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021261Orig1s009lbl.pdf
02/02/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21261lbl.pdf