Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071345
Company: WATSON LABS

Products on ANDA 071345

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071345

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/1987	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
08/09/2024	SUPPL-42	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
05/19/2020	SUPPL-38	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/24/2003	SUPPL-18	Labeling		Label is not available on this site.
04/25/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
06/08/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/01/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/17/1996	SUPPL-12	Labeling		Label is not available on this site.
05/13/1993	SUPPL-11	Labeling		Label is not available on this site.
01/28/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/07/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/07/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/01/1988	SUPPL-5	Labeling		Label is not available on this site.
03/01/1988	SUPPL-4	Labeling		Label is not available on this site.
08/12/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/12/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071345

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