Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083149
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PBZ TRIPELENNAMINE HYDROCHLORIDE 25MG TABLET;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
09/06/1973 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
07/20/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/30/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/16/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/16/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/12/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/12/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/12/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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