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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Citi
QuintilesIMS
US Army
McKesson
Queensland Health
Express Scripts
UBS
Fish and Richardson

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040525

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NDA 040525 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 040525
Tradename:PHENTERMINE HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:phentermine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040525
Suppliers and Packaging for NDA: 040525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040525 ANDA Apotheca Inc. 12634-547 N 12634-547-00
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040525 ANDA Apotheca Inc. 12634-547 N 12634-547-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Oct 23, 2003TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Dow
AstraZeneca
Farmers Insurance
Fuji
Medtronic
McKinsey
Boehringer Ingelheim
Merck

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