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FDA NDA · NDA005914

PBZ

Sponsor: NOVARTIS

APPLICATION
NDA005914
TYPE
NDA
ORIGINAL APPROVAL
1948-02-19
LATEST ACTION
1999-04-23
ROUTE
ORAL
DOSAGE FORM
ELIXIR, TABLET
MARKETING STATUS
Discontinued

Products

PBZDiscontinued
TRIPELENNAMINE CITRATE EQ 25MG HYDROCHLORIDE/5ML · ELIXIR · ORAL
PBZDiscontinued
TRIPELENNAMINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

1999-04-23Manufacturing (CMC) · Supplement 38 · standardAP
1998-03-24Efficacy · Supplement 30AP
1948-02-19Type 1 - New Molecular Entity · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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