Details for New Drug Application (NDA): 009866

NDA 009866 describes SOLU-CORTEF, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the SOLU-CORTEF profile page.

The generic ingredient in SOLU-CORTEF 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 009866

Tradename:	SOLU-CORTEF
Applicant:	Pharmacia And Upjohn
Ingredient:	hydrocortisone sodium succinate
Patents:	0

Pharmacology for NDA: 009866

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 009866

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SOLU-CORTEF	hydrocortisone sodium succinate	INJECTABLE;INJECTION	009866	NDA	Pharmacia & Upjohn Company LLC	0009-0005	0009-0005-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE
SOLU-CORTEF	hydrocortisone sodium succinate	INJECTABLE;INJECTION	009866	NDA	Pharmacia & Upjohn Company LLC	0009-0011	0009-0011-04	25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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