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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 040491


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NDA 040491 describes DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, which is a drug marketed by Amneal, Fresenius Kabi Usa, and Somerset Theraps Llc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE profile page.

The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 040491
Tradename:DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:dexamethasone sodium phosphate
Patents:0
Pharmacology for NDA: 040491
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 040491
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 040491 ANDA Fresenius Kabi USA, LLC 63323-506 63323-506-01 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL (63323-506-00)
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 040491 ANDA Fresenius Kabi USA, LLC 63323-506 63323-506-13 25 VIAL in 1 TRAY (63323-506-13) / 1 mL in 1 VIAL (63323-506-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG PHOSPHATE/ML
Approval Date:Apr 11, 2003TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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