Details for New Drug Application (NDA): 217191
NDA 217191 describes HYDROCORTISONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Watson Labs, and Zydus Pharms, and is included in seventeen NDAs. It is available from four suppliers. Additional details are available on the HYDROCORTISONE SODIUM SUCCINATE profile page.
The generic ingredient in HYDROCORTISONE SODIUM SUCCINATE is hydrocortisone sodium succinate. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.
The generic ingredient in HYDROCORTISONE SODIUM SUCCINATE is hydrocortisone sodium succinate. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.
Summary for 217191
| Tradename: | HYDROCORTISONE SODIUM SUCCINATE |
| Applicant: | Zydus Pharms |
| Ingredient: | hydrocortisone sodium succinate |
| Patents: | 0 |
Pharmacology for NDA: 217191
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 217191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE SODIUM SUCCINATE | hydrocortisone sodium succinate | INJECTABLE;INJECTION | 217191 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1907 | 70710-1907-1 | 1 VIAL in 1 CARTON (70710-1907-1) / 2 mL in 1 VIAL |
| HYDROCORTISONE SODIUM SUCCINATE | hydrocortisone sodium succinate | INJECTABLE;INJECTION | 217191 | ANDA | Zydus Lifesciences Limited | 70771-1966 | 70771-1966-1 | 1 VIAL in 1 CARTON (70771-1966-1) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | May 7, 2026 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
