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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 2017

DrugPatentWatch Database Preview

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 Fresenius Kabi Usa and is included in one NDA. It is available from four 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-two suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

Summary for NDA: 040491

Pharmacology for NDA: 040491

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 Cardinal Health 55154-9371 55154-9371-5 5 VIAL in 1 BAG (55154-9371-5) > 1 mL in 1 VIAL
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
dexamethasone sodium phosphate
INJECTABLE;INJECTION 040491 ANDA Proficient Rx LP 63187-348 63187-348-01 1 KIT in 1 CARTON (63187-348-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1559-10) * .9 mL in 1 PACKET (67777-130-02) * 5 mL in 1 POUCH (53329-820-09) * 2 mL in 1 AMPULE (0409-4713-32) * 1 mL in 1 VIAL (63323-506-01)

Summary 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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Serving 500+ biopharmaceutical companies globally:

McKinsey
Medtronic
US Army
QuintilesIMS
Cipla
Farmers Insurance
Daiichi Sankyo
Cantor Fitzgerald
McKesson
Federal Trade Commission

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