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Serving 500+ biopharmaceutical companies globally:

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Generated: July 21, 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 eight 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 NDA: 084307

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0641-0493-25 25 VIAL in 1 CARTON (0641-0493-25) > 2 mL in 1 VIAL (0641-0493-21)
PHENYTOIN SODIUM
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 500+ biopharmaceutical companies globally:

Chubb
US Department of Justice
Dow
Moodys
Cerilliant
Novartis
Farmers Insurance
Baxter
Chinese Patent Office
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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