Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084310
Company: IMPAX LABS

Products on ANDA 084310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLTESTOSTERONE	METHYLTESTOSTERONE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/1974	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
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-76	Labeling		Label is not available on this site.
05/07/2002	SUPPL-75	Labeling		Label is not available on this site.
05/07/2002	SUPPL-74	Manufacturing (CMC)-Facility		Label is not available on this site.
08/13/1999	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
03/10/2000	SUPPL-72	Labeling		Label is not available on this site.
10/29/1997	SUPPL-71	Labeling		Label is not available on this site.
10/09/1991	SUPPL-70	Labeling		Label is not available on this site.
07/05/1991	SUPPL-69	Labeling		Label is not available on this site.
07/05/1991	SUPPL-68	Labeling		Label is not available on this site.
01/19/1990	SUPPL-67	Labeling		Label is not available on this site.
10/23/1989	SUPPL-65	Labeling		Label is not available on this site.
06/22/1989	SUPPL-64	Labeling		Label is not available on this site.
10/31/1988	SUPPL-63	Labeling		Label is not available on this site.
07/06/1988	SUPPL-62	Labeling		Label is not available on this site.