Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091366
Company: PERRIGO R AND D

Products on ANDA 091366

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091366

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/2010	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-1	Labeling-Package Insert		Label is not available on this site.

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

MICONAZOLE NITRATE

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	TARO
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