Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080767
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLTESTOSTERONE METHYLTESTOSTERONE 10MG TABLET;ORAL Prescription BP 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
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.

METHYLTESTOSTERONE

There are no Therapeutic Equivalents.

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