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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089452

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NDA 089452 describes PHENDIMETRAZINE TARTRATE, which is a drug marketed by Graham Dm, 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 089452
Ingredient:phendimetrazine tartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 089452
Suppliers and Packaging for NDA: 089452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate TABLET;ORAL 089452 ANDA C.O. Truxton, Inc. 0463-7500 N 0463-7500-01
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate TABLET;ORAL 089452 ANDA C.O. Truxton, Inc. 0463-7500 N 0463-7500-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Oct 30, 1991TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Queensland Health

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