Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087147
Company: VALEANT PHARM INTL

Products on ANDA 087147

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANDROID 25	METHYLTESTOSTERONE	25MG	TABLET;ORAL	Prescription	BP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/1981	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
10/25/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/11/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/19/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/16/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/16/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/16/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/16/1996	SUPPL-8	Labeling		Label is not available on this site.
10/16/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/16/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-5	Labeling		Label is not available on this site.
06/23/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/11/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087147

ANDROID 25

There are no Therapeutic Equivalents.