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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084916

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NDA 084916 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Fresenius Kabi Usa, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in twenty-eight NDAs. It is available from nineteen 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-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

Summary for 084916

Pharmacology for NDA: 084916

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 Cardinal Health 55154-9364 55154-9364-5 5 VIAL in 1 BAG (55154-9364-5) > 1 mL in 1 VIAL
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 084916 ANDA Cardinal Health 55154-9364 55154-9364-8 1 VIAL in 1 BAG (55154-9364-8) > 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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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Citi
Covington
Express Scripts
Novartis
AstraZeneca
Queensland Health
Colorcon
Farmers Insurance
Daiichi Sankyo

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