Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084310
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLTESTOSTERONE METHYLTESTOSTERONE 25MG TABLET;ORAL Discontinued None No No
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.

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