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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075598
Company: PERRIGO

Products on ANDA 075598

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075598

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2001	ORIG-1	Approval			Letter (PDF) Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75598ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75598ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075598Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2008	SUPPL-18	Labeling		Label is not available on this site.
07/14/2005	SUPPL-13	Labeling		Label is not available on this site.
08/30/2005	SUPPL-9	Labeling		Label is not available on this site.
08/09/2004	SUPPL-4	Labeling		Label is not available on this site.

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

MINOXIDIL EXTRA STRENGTH (FOR MEN)

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

SOLUTION;TOPICAL; 5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	075438	AUROBINDO PHARMA LTD
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	075518	P AND L
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	075598	PERRIGO
ROGAINE EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	Yes	020834	JOHNSON AND JOHNSON
THEROXIDIL	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	076239	PURE SOURCE

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