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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200691

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NDA 200691 describes PHENYTOIN, which is a drug marketed by Vistapharm, Wockhardt, Taro, Corepharma, Mylan Pharms Inc, Actavis Mid Atlantic, Warner Chilcott, Marsam Pharms Llc, Fresenius Kabi Usa, West-ward Pharms Int, Aurobindo Pharma Ltd, Smith And Nephew, Solopak, Hospira, Watson Labs, Pharmeral, X-gen Pharms, and Luitpold, and is included in twenty-four NDAs. It is available from thirteen suppliers. Additional details are available on the PHENYTOIN profile page.

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

Summary for NDA: 200691

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200691

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN
phenytoin
TABLET, CHEWABLE;ORAL 200691 ANDA Mylan Pharmaceuticals Inc. 0378-3850 0378-3850-01 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-01)
PHENYTOIN
phenytoin
TABLET, CHEWABLE;ORAL 200691 ANDA Mylan Pharmaceuticals Inc. 0378-3850 0378-3850-05 500 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength50MG
Approval Date:Dec 26, 2012TE:ABRLD:No


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