Sold as Pbz, Pbz-Sr. Every FDA application for this active ingredient: 2 branded and 12 generic.
As of Nov 15, 2026, FDA lists 14 applications for Tripelennamine Hydrochloride (sold as Pbz, Pbz-Sr), first approved Feb 19, 1948, with 2 new uses approved and 0 published complete response letters.
| Feb 19, 1948 | PbzNDA 5914 · New molecular entity | Novartis | 2 | Discontinued |
| Jul 5, 1956 | Pbz-SrNDA 10533 · New formulation or manufacturer | Novartis | 13 | Discontinued |
| Sep 27, 1972 | Tripelennamine HydrochlorideANDA 80744 | Barr | 0 | Discontinued |
| Jan 18, 1973 | Tripelennamine HydrochlorideANDA 80713 | Watson Labs | 12 | Discontinued |
| Sep 6, 1973 | PbzANDA 83149 | Novartis | 10 | Discontinued |
| May 10, 1974 | Tripelennamine HydrochlorideANDA 83557 | Lannett | 1 | Discontinued |
| Aug 11, 1976 | Tripelennamine HydrochlorideANDA 85188 | Watson Labs | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 80785 | Impax Labs | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 80790 | Watson Labs | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 83037 | Anabolic | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 83625 | Parke Davis | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 83626 | Parke Davis | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 83989 | Heather | 0 | Discontinued |
| — | Tripelennamine HydrochlorideANDA 85412 | Nylos | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA