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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202248

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NDA 202248 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 thirty-three 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. Thirty-five suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
Summary for 202248
Tradename:PHENTERMINE HYDROCHLORIDE
Applicant:Elite Labs
Ingredient:phentermine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202248
Suppliers and Packaging for NDA: 202248
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 202248 ANDA PD-Rx Pharmaceuticals, Inc. 43063-646 N 43063-646-07
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 202248 ANDA PD-Rx Pharmaceuticals, Inc. 43063-646 N 43063-646-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Sep 28, 2012TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Sep 28, 2012TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Cantor Fitzgerald
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Colorcon
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Chinese Patent Office
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