NDA 10347, held by Bristol Myers Squibb. Hydroxyprogesterone Caproate.
As of Nov 13, 2026, NDA 10347 (Delalutin), held by Bristol Myers Squibb, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Delalutin250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular | Hydroxyprogesterone Caproate | DiscontinuedReference drug |
| Delalutin125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular | Hydroxyprogesterone Caproate | DiscontinuedReference drug |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
