Details for New Drug Application (NDA): 214050
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NDA 214050 describes HYDROCORTISONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Cipla, Intl Medication, and Watson Labs, and is included in fifteen NDAs. It is available from one supplier. Additional details are available on the HYDROCORTISONE SODIUM SUCCINATE profile page.
The generic ingredient in HYDROCORTISONE SODIUM SUCCINATE is hydrocortisone sodium succinate. There are sixty-seven drug master file entries for this compound. Four 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 are sixty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.
Summary for 214050
| Tradename: | HYDROCORTISONE SODIUM SUCCINATE |
| Applicant: | Cipla |
| Ingredient: | hydrocortisone sodium succinate |
| Patents: | 0 |
Pharmacology for NDA: 214050
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 214050
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE SODIUM SUCCINATE | hydrocortisone sodium succinate | INJECTABLE;INJECTION | 214050 | ANDA | Cipla USA Inc. | 69097-004 | 69097-004-67 | 1 VIAL in 1 CARTON (69097-004-67) / 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: | Sep 5, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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