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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Covington
Teva
UBS
AstraZeneca
Federal Trade Commission
Julphar
Medtronic
Baxter

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040228

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NDA 040228 describes PHENTERMINE HYDROCHLORIDE, which is a drug marketed by Abc Holding, Able, Aurolife Pharma Llc, Barr, Camall, Chartwell Rx, Duramed Pharms Barr, Elite Labs, Elite Labs Inc, Invagen Pharms, Ivax Pharms, Ken Lifescience, Kvk Tech, Lannett, Lannett Co Inc, Sandoz, Sun Pharm Industries, Teva, Tg United Inc, Upsher-smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Ingenus Pharms Nj, Kvk Tech Inc, Polygen Pharms, Prinston Inc, Sandoz Inc, and Sun Pharm Inds Inc, and is included in eighty-seven NDAs. It is available from forty-six suppliers. Additional details are available on the PHENTERMINE HYDROCHLORIDE profile page.

The generic ingredient in PHENTERMINE HYDROCHLORIDE is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
Summary for 040228
Tradename:PHENTERMINE HYDROCHLORIDE
Applicant:Elite Labs Inc
Ingredient:phentermine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040228
Suppliers and Packaging for NDA: 040228
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040228 ANDA Epic Pharma, LLC 42806-524 N 42806-524-01
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040228 ANDA Epic Pharma, LLC 42806-524 N 42806-524-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength37.5MG
Approval Date:Jun 19, 1997TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Julphar
US Army
Healthtrust
Covington
Citi
Baxter
Medtronic

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