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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Federal Trade Commission
Citi
Accenture
QuintilesIMS
AstraZeneca
McKinsey
Queensland Health
Express Scripts

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201961

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NDA 201961 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 Holdings 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 201961
Tradename:PHENTERMINE HYDROCHLORIDE
Applicant:Lannett Holdings Inc
Ingredient:phentermine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201961
Suppliers and Packaging for NDA: 201961
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 201961 ANDA Lannett Company, Inc. 0527-1743 N 0527-1743-10
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 201961 ANDA Lannett Company, Inc. 0527-1743 N 0527-1743-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength37.5MG
Approval Date:Jul 20, 2011TE:AARLD:No

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