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Last Updated: November 23, 2024

Details for New Drug Application (NDA): 040802


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NDA 040802 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Amneal, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Gland Pharma Ltd, Hikma, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz, and is included in forty NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 040802
Pharmacology for NDA: 040802
Suppliers and Packaging for NDA: 040802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 040802 ANDA Henry Schein, Inc. 0404-9842 0404-9842-10 1 VIAL, MULTI-DOSE in 1 BAG (0404-9842-10) / 10 mL in 1 VIAL, MULTI-DOSE
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 040802 ANDA Mylan Institutional LLC 67457-420 67457-420-10 10 VIAL in 1 CARTON (67457-420-10) / 10 mL in 1 VIAL (67457-420-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG PHOSPHATE/ML
Approval Date:Aug 29, 2008TE:APRLD:No

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