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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Cantor Fitzgerald
Queensland Health
US Army
Chinese Patent Office

Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084307

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NDA 084307 describes PHENYTOIN SODIUM, which is a drug marketed by Warner Chilcott, Marsam Pharms Llc, Fresenius Kabi Usa, West-ward Pharms Int, Aurobindo Pharma Ltd, Smith And Nephew, Solopak, Hospira, Watson Labs, Pharmeral, Acella Pharms Llc, and Luitpold, and is included in sixteen NDAs. It is available from seven suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 084307

Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 084307

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
phenytoin sodium
INJECTABLE;INJECTION 084307 ANDA West-Ward Pharmaceuticals Corp. 0641-0493 0641-0493-25 25 VIAL in 1 CARTON (0641-0493-25) > 2 mL in 1 VIAL (0641-0493-21)
phenytoin sodium
INJECTABLE;INJECTION 084307 ANDA West-Ward Pharmaceuticals Corp. 0641-2555 0641-2555-45 25 VIAL in 1 CARTON (0641-2555-45) > 5 mL in 1 VIAL (0641-2555-41)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Boehringer Ingelheim
Federal Trade Commission

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