Treats advanced adenocarcinoma of the uterine corpus (Stage III or IV). ANDA 211142, held by Eugia Pharma. Hydroxyprogesterone Caproate.
As of Nov 14, 2026, ANDA 211142 (Hydroxyprogesterone Caproate), held by Eugia Pharma, was first approved by FDA on May 9, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyprogesterone Caproate1250MG/5ML (250MG/ML) · solution;intramuscular | Hydroxyprogesterone Caproate | Discontinued |
| May 24, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 9, 2019 | Original application | Approved | None posted |
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
