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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075518
Company: P AND L

Products on ANDA 075518

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 075518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75518ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75518ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2013	SUPPL-24	Labeling		Label is not available on this site.
05/17/2005	SUPPL-12	Labeling		Label is not available on this site.
06/15/2005	SUPPL-11	Labeling		Label is not available on this site.
04/12/2005	SUPPL-7	Labeling		Label is not available on this site.
10/04/2002	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/31/2001	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/31/2001	SUPPL-2	Labeling		Label is not available on this site.
10/31/2001	SUPPL-1	Manufacturing (CMC)-Packaging		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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