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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074926
Company: P AND L

Products on ANDA 074926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
M-ZOLE 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074926

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole%20Nitrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74926ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2018	SUPPL-18	Labeling-Container/Carton Labels		Label is not available on this site.
04/08/2005	SUPPL-8	Labeling		Label is not available on this site.
08/14/2003	SUPPL-6	Labeling		Label is not available on this site.
11/21/2002	SUPPL-4	Labeling		Label is not available on this site.
03/15/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 074926

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole%20Nitrate_Prntlbl.pdf

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

M-ZOLE 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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