Sold as Sparine. Every FDA application for this active ingredient: 3 branded and 2 generic.
As of Nov 15, 2026, FDA lists 5 applications for Promazine Hydrochloride (sold as Sparine), first approved Apr 13, 1956, with 0 new uses approved and 0 published complete response letters.
| Apr 13, 1956 | SparineNDA 10349 · New molecular entity | Hikma | 0 | Discontinued |
| Apr 8, 1957 | SparineNDA 10348 · New dosage form | Wyeth Ayerst | 0 | Discontinued |
| Nov 12, 1957 | SparineNDA 10942 · New dosage form | Wyeth Ayerst | 1 | Discontinued |
| — | Promazine HydrochlorideANDA 84510 | Watson Labs | 0 | Discontinued |
| — | Promazine HydrochlorideANDA 84517 | Watson Labs | 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
Hikma