Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076239
Company: PURE SOURCE

Products on ANDA 076239

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2004	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
07/21/2016	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/21/2016	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

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

THEROXIDIL

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