Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074767
Company: AUROBINDO PHARMA LTD

Products on ANDA 074767

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074767

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1997	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
11/25/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/25/1997	SUPPL-1	Labeling		Label is not available on this site.

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

MINOXIDIL (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; 2%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	No	074767	AUROBINDO PHARMA LTD
MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	No	075357	L PERRIGO CO
MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	No	074588	P AND L
MINOXIDIL (FOR WOMEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	No	075357	L PERRIGO CO
ROGAINE (FOR MEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	Yes	019501	JOHNSON AND JOHNSON
ROGAINE (FOR WOMEN)	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	Yes	019501	JOHNSON AND JOHNSON
THEROXIDIL	MINOXIDIL	2%	SOLUTION;TOPICAL	Over-the-counter	No	078176	PURE SOURCE