Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076357
Company: PERRIGO

Products on ANDA 076357

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076357

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2017	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
04/12/2005	SUPPL-5	Labeling		Label is not available on this site.

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

MICONAZOLE 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;TOPICAL, VAGINAL; 2%,4%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MICONAZOLE 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,4%	CREAM;TOPICAL, VAGINAL	Over-the-counter	No	076357	PERRIGO
MONISTAT 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,4%	CREAM;TOPICAL, VAGINAL	Over-the-counter	Yes	021261	MEDTECH PRODUCTS
MONISTAT 3 COMBINATION PACK (PREFILLED)	MICONAZOLE NITRATE	2%,4%	CREAM;TOPICAL, VAGINAL	Over-the-counter	Yes	021261	MEDTECH PRODUCTS