NDA 21190, held by Bristol Myers Squibb. Buspirone Hydrochloride.
As of Nov 14, 2026, NDA 21190 (Buspar), held by Bristol Myers Squibb, was first approved by FDA on Dec 20, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Buspar5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Buspirone Hydrochloride | DiscontinuedReference drug |
| Buspar7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Buspirone Hydrochloride | DiscontinuedReference drug |
| Buspar10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Buspirone Hydrochloride | DiscontinuedReference drug |
| Buspar15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Buspirone Hydrochloride | DiscontinuedReference drug |
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
