Details for New Drug Application (NDA): 040612

NDA 040612 describes METHYLPREDNISOLONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Amneal, Bedford Labs, Elkins Sinn, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, and Watson Labs, and is included in thirty-three NDAs. It is available from seven suppliers. Additional details are available on the METHYLPREDNISOLONE SODIUM SUCCINATE profile page.

The generic ingredient in METHYLPREDNISOLONE SODIUM SUCCINATE is methylprednisolone sodium succinate. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the methylprednisolone sodium succinate profile page.

Summary for 040612

Tradename:	METHYLPREDNISOLONE SODIUM SUCCINATE
Applicant:	Fresenius Kabi Usa
Ingredient:	methylprednisolone sodium succinate
Patents:	0

Pharmacology for NDA: 040612

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 040612

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040612	ANDA	Fresenius Kabi USA, LLC	63323-265	63323-265-30	1 VIAL, MULTI-DOSE in 1 CARTON (63323-265-30) / 16 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Aug 12, 2004	TE:	AP	RLD:	No

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