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Generated: January 23, 2019

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Details for New Drug Application (NDA): 040765

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NDA 040765 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms Inc, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Wockhardt, and Wockhardt Usa, and is included in nine NDAs. It is available from twenty-six suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.

The generic ingredient in EXTENDED PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 040765
Applicant:Amneal Pharms Ny
Ingredient:phenytoin sodium
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040765 ANDA Major Pharmaceuticals 0904-6187 0904-6187-61 100 BLISTER PACK in 1 CARTON (0904-6187-61) > 1 CAPSULE in 1 BLISTER PACK
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040765 ANDA Marlex Pharmaceuticals Inc 10135-603 10135-603-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-603-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG EXTENDED
Approval Date:Nov 12, 2008TE:ABRLD:No

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