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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091042

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NDA 091042 describes PHENDIMETRAZINE TARTRATE, which is a drug marketed by Graham Dm, Virtus Pharms, Sandoz, Vitarine, Barr, Chartwell Rx, Elite Labs Inc, Ferndale Labs, Inwood Labs, Ivax Pharms, Ivax Sub Teva Pharms, Kv Pharm, Kvk Tech, Mfg Chemists, Mikart, Nexgen Pharma Inc, Numark, Pvt Form, Solvay, Usl Pharma, and Watson Labs, and is included in sixty-five NDAs. It is available from twenty-three suppliers. Additional details are available on the PHENDIMETRAZINE TARTRATE profile page.

The generic ingredient in PHENDIMETRAZINE TARTRATE is phendimetrazine tartrate. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.
Summary for 091042
Tradename:PHENDIMETRAZINE TARTRATE
Applicant:Kvk Tech
Ingredient:phendimetrazine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091042
Suppliers and Packaging for NDA: 091042
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate TABLET;ORAL 091042 ANDA Blenheim Pharmacal, Inc. 10544-041 E 10544-041-30
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate TABLET;ORAL 091042 ANDA KVK-TECH, INC 10702-045 N 10702-045-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Aug 31, 2010TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
Johnson and Johnson
Colorcon
Mallinckrodt
Citi
Deloitte
Merck
Queensland Health

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