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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
Queensland Health
Federal Trade Commission
Covington
Fuji
Deloitte
Medtronic
Fish and Richardson

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085588

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NDA 085588 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 085588
Tradename:PHENDIMETRAZINE TARTRATE
Applicant:Virtus Pharms
Ingredient:phendimetrazine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 085588
Suppliers and Packaging for NDA: 085588
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate TABLET;ORAL 085588 ANDA Eon Labs, Inc. 0185-4057 N 0185-4057-01
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate TABLET;ORAL 085588 ANDA Eon Labs, Inc. 0185-4057 N 0185-4057-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cerilliant
UBS
Chubb
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Farmers Insurance
Julphar
Mallinckrodt
Accenture

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