Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019762
Company: ALZA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTODERM TESTOSTERONE 4MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
TESTODERM TESTOSTERONE 6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
10/12/1993 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/17/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1996 SUPPL-2 Labeling

Label is not available on this site.

06/26/1996 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

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