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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
AstraZeneca
Express Scripts
Federal Trade Commission
Argus Health
US Army
US Department of Justice
Merck
Citi

Generated: April 22, 2018

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

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 084307
Tradename:PHENYTOIN SODIUM
Applicant:West-ward Pharms Int
Ingredient:phenytoin sodium
Patents:0
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 phenytoin sodium INJECTABLE;INJECTION 084307 ANDA West-Ward Pharmaceuticals Corp. 0641-0493 N 0641-0493-25
PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 084307 ANDA West-Ward Pharmaceuticals Corp. 0641-2555 N 0641-2555-45

Profile 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 hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Daiichi Sankyo
UBS
Julphar
Cantor Fitzgerald
Federal Trade Commission
QuintilesIMS
Covington

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