Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080767
Company: IMPAX LABS

Products on ANDA 080767

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080767

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/1974	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-82	Labeling-Package Insert		Label is not available on this site.
05/11/2015	SUPPL-78	Labeling-Package Insert		Label is not available on this site.
06/19/2014	SUPPL-77	Labeling-Package Insert		Label is not available on this site.
11/04/2002	SUPPL-67	Labeling		Label is not available on this site.
03/08/2002	SUPPL-66	Labeling		Label is not available on this site.
03/08/2002	SUPPL-65	Manufacturing (CMC)-Facility		Label is not available on this site.
03/10/2000	SUPPL-64	Labeling		Label is not available on this site.
10/29/1997	SUPPL-63	Labeling		Label is not available on this site.
10/09/1991	SUPPL-62	Labeling		Label is not available on this site.
07/05/1991	SUPPL-61	Labeling		Label is not available on this site.
01/19/1990	SUPPL-60	Labeling		Label is not available on this site.
07/20/1989	SUPPL-59	Labeling		Label is not available on this site.
07/20/1989	SUPPL-58	Labeling		Label is not available on this site.
10/31/1988	SUPPL-57	Labeling		Label is not available on this site.
07/06/1988	SUPPL-55	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 080767

METHYLTESTOSTERONE

There are no Therapeutic Equivalents.