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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091344
Company: PERRIGO PHARMA INTL

Products on ANDA 091344

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091344

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091344s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2020	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
03/03/2017	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/13/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.

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

MINOXIDIL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

AEROSOL, FOAM;TOPICAL; 5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	Yes	021812	JOHNSON AND JOHNSON
MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	091344	PERRIGO PHARMA INTL
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	208092	P AND L
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	209074	TARO
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	208092	P AND L
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	209074	TARO
WOMEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	Yes	021812	JOHNSON AND JOHNSON

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