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Generated: January 19, 2019

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Details for New Drug Application (NDA): 018074

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NDA 018074 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.
Summary for 018074
Tradename:PHENDIMETRAZINE TARTRATE
Applicant:Virtus Pharms
Ingredient:phendimetrazine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018074
Suppliers and Packaging for NDA: 018074
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate CAPSULE, EXTENDED RELEASE;ORAL 018074 NDA Eon Labs, Inc. 0185-5254 0185-5254-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0185-5254-01)
PHENDIMETRAZINE TARTRATE phendimetrazine tartrate CAPSULE, EXTENDED RELEASE;ORAL 018074 NDA Eon Labs, Inc. 0185-5254 0185-5254-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0185-5254-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength105MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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