Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020791
Company: ALZA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTODERM TTS TESTOSTERONE 5MG/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
12/18/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020791_testoderm_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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