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Generated: June 17, 2019

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Details for New Drug Application (NDA): 040573

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NDA 040573 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 nine suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 040573
Tradename:PHENYTOIN SODIUM
Applicant:Acella Pharms Llc
Ingredient:phenytoin sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040573
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 040573 ANDA X-GEN Pharmaceuticals, Inc. 39822-4050 39822-4050-3 25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-3) > 2 mL in 1 VIAL, SINGLE-DOSE (39822-4050-2)
PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 040573 ANDA X-GEN Pharmaceuticals, Inc. 39822-4050 39822-4050-6 25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Sep 13, 2006TE:APRLD:No

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