ANDA 200271, held by Aspen Global Inc. Hydroxyprogesterone Caproate.
As of Nov 14, 2026, ANDA 200271 (Hydroxyprogesterone Caproate), held by Aspen Global Inc, was first approved by FDA on Aug 24, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 24, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyprogesterone Caproate1250MG/5ML (250MG/ML) ยท solution;intramuscular | Hydroxyprogesterone Caproate | Discontinued |
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
