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Details for New Drug Application (NDA): 084916

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NDA 084916 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Eurohlth Intl Sarl, Mylan Labs Ltd, Watson Labs, Fresenius Kabi Usa, Intl Medication, Teva Parenteral, Luitpold, Wyeth Ayerst, Bel Mar, Akorn, Dell Labs, Lyphomed, Bausch And Lomb, Sola Barnes Hind, Alcon Pharms Ltd, and Aurobindo Pharma Ltd, and is included in twenty-eight NDAs. It is available from twenty-four suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE profile page.

The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There are thirty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

Suppliers and Packaging for NDA: 084916

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION 084916 ANDA A-S Medication Solutions 50090-0414 50090-0414-0 1 VIAL, MULTI-DOSE in 1 BOX (50090-0414-0) > 30 mL in 1 VIAL, MULTI-DOSE
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION 084916 ANDA A-S Medication Solutions 50090-1715 50090-1715-0 25 VIAL in 1 TRAY (50090-1715-0) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG PHOSPHATE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No


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