Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071839
Company: ENDO OPERATIONS

Products on ANDA 071839

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071839

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/1988	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
04/10/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/28/2014	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/21/2003	SUPPL-5	Labeling		Label is not available on this site.
11/26/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/26/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/02/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/08/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071839

MINOXIDIL

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	No	AB	071839	ENDO OPERATIONS
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	No	AB	072709	SUN PHARM INDUSTRIES
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	No	AB	071345	WATSON LABS