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Details for New Drug Application (NDA): 040666

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NDA 040666 describes A-HYDROCORT, which is a drug marketed by Abbott and Hospira and is included in ten NDAs. It is available from one supplier. Additional details are available on the A-HYDROCORT profile page.

The generic ingredient in A-HYDROCORT is hydrocortisone sodium succinate. There are fifty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.

Summary for NDA: 040666

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040666

Suppliers and Packaging for NDA: 040666

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone sodium succinate
INJECTABLE;INJECTION 040666 ANDA Hospira, Inc. 0409-4856 0409-4856-05 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-4856-05) > 2 mL in 1 VIAL, SINGLE-DOSE
hydrocortisone sodium succinate
INJECTABLE;INJECTION 040666 ANDA Hospira, Inc. 0409-4856 0409-4856-15 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4856-15) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Apr 6, 2006TE:APRLD:No

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