Pbz

NDA 5914, held by Novartis. Tripelennamine Hydrochloride, Tripelennamine Citrate.

As of Nov 14, 2026, NDA 5914 (Pbz), held by Novartis, was first approved by FDA on Feb 19, 1948, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 19, 1948
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Mar 24, 1998	Supplement 30Efficacy (new indication or use)	Approved	None posted
Feb 19, 1948	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Pbz50MG · tablet;oral	Tripelennamine Hydrochloride	Discontinued
PbzEQ 25MG HYDROCHLORIDE/5ML · elixir;oral	Tripelennamine Citrate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 23, 1999	Supplement 38Manufacturing · Standard review	Approved	None posted
Mar 24, 1998	Supplement 30Efficacy (new indication or use)	Approved	None posted
Feb 19, 1948	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 5914
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Pbz