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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 207442


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NDA 207442 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. Eighteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 207442
Tradename:DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Applicant:Somerset Theraps Llc
Ingredient:dexamethasone sodium phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207442
Suppliers and Packaging for NDA: 207442
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 207442 ANDA Somerset Therapeutics, LLC 70069-021 70069-021-25 25 VIAL in 1 CARTON (70069-021-25) / 1 mL in 1 VIAL (70069-021-01)
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 207442 ANDA REMEDYREPACK INC. 70518-1922 70518-1922-1 25 VIAL in 1 CARTON (70518-1922-1) / 1 mL in 1 VIAL (70518-1922-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG PHOSPHATE/ML
Approval Date:Apr 19, 2018TE:APRLD:No

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