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Last Updated: March 27, 2026

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, Apotex, Baxter Hlthcare, Cipla, Intl Medication, and Watson Labs, and is included in sixteen 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. Five 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

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