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Serving leading biopharmaceutical companies globally:

Harvard Business School
Citi
Baxter
Fuji
Boehringer Ingelheim
Teva
Medtronic
Cantor Fitzgerald
US Army
Merck

Generated: January 19, 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 Holdings Inc, Mikah Pharma, 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-five 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-seven 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 12634-547-80 20 CAPSULE in 1 BOTTLE (12634-547-80)
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040525 ANDA Apotheca Inc. 12634-547 12634-547-74 24 CAPSULE in 1 BOTTLE (12634-547-74)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Citi
Covington
Farmers Insurance
Fuji
US Department of Justice
Chubb
Mallinckrodt
Fish and Richardson
Johnson and Johnson

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