Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010533
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PBZ-SR TRIPELENNAMINE HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
PBZ-SR TRIPELENNAMINE HYDROCHLORIDE 50MG TABLET, EXTENDED RELEASE;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
07/05/1956 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/19/1992 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-27 Labeling

Label is not available on this site.

03/20/1998 SUPPL-24 Efficacy-New Indication

Label is not available on this site.

12/07/2007 SUPPL-21 Labeling

Label is not available on this site.

12/07/2007 SUPPL-20 Labeling

Label is not available on this site.

12/07/2007 SUPPL-19 Labeling

Label is not available on this site.

12/07/2007 SUPPL-18 Labeling

Label is not available on this site.

12/07/2007 SUPPL-17 Labeling

Label is not available on this site.

12/07/2007 SUPPL-15 Labeling

Label is not available on this site.

12/07/2007 SUPPL-10 Labeling

Label is not available on this site.

12/07/2007 SUPPL-8 Labeling

Label is not available on this site.

12/07/2007 SUPPL-4 Labeling

Label is not available on this site.

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