Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005914
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PBZ TRIPELENNAMINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
PBZ TRIPELENNAMINE CITRATE EQ 25MG HYDROCHLORIDE/5ML ELIXIR;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
02/19/1948 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/23/1999 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1998 SUPPL-30 Efficacy-New Indication

Label is not available on this site.

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