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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072709
Company: SUN PHARM INDUSTRIES

Products on ANDA 072709

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	AB	No	No
MINOXIDIL	MINOXIDIL	2.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072709

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/1995	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
05/15/2018	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
06/16/2004	SUPPL-11	Labeling		Label is not available on this site.
06/06/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
12/05/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/24/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/28/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072709

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	PH HEALTH
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	No	AB	072709	SUN PHARM INDUSTRIES
MINOXIDIL	MINOXIDIL	10MG	TABLET;ORAL	Prescription	No	AB	071345	WATSON LABS

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MINOXIDIL	MINOXIDIL	2.5MG	TABLET;ORAL	Prescription	No	AB	071826	PH HEALTH
MINOXIDIL	MINOXIDIL	2.5MG	TABLET;ORAL	Prescription	No	AB	072709	SUN PHARM INDUSTRIES
MINOXIDIL	MINOXIDIL	2.5MG	TABLET;ORAL	Prescription	No	AB	071344	WATSON LABS

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