Active substance
Hydroxyprogesterone caproate
- SFDA 1
- US FDA 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PROLUTON DEPOT AMP 250MG-ML(500mg-2ML) | 250 mg/ml | Solution for injection · Intramuscular use | 1 Ampoule | SAR 20.45 | NCE · Prescription | BAYER PHARMA AG | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HYDROXYPROGESTERONE CAPROATE | 125MG/ML; 250MG/ML | injectable · injection | ALLERGAN | Discontinued | 26 Dec 1974 |
| HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | solution · intramuscular | ASPEN GLOBAL INC | Discontinued | 24 Aug 2015 |
| HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | solution · intramuscular | EUGIA PHARMA | Discontinued | 9 May 2019 |
| HYDROXYPROGESTERONE CAPROATE | 125MG/ML | injectable · injection | QUAD PHARMS | Discontinued | |
| HYDROXYPROGESTERONE CAPROATE | 250MG/ML | injectable · injection | QUAD PHARMS | Discontinued | |
| DELALUTIN | 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intramuscular | BRISTOL MYERS SQUIBB | Discontinued | |
| DELALUTIN | 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intramuscular | BRISTOL MYERS SQUIBB | Discontinued | |
| HYDROXYPROGESTERONE CAPROATE | 125MG/ML | injectable · injection | EPIC PHARMA LLC | Discontinued |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.