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Generated: December 15, 2017

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 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 040228

Tradename:1
Applicant:1
Ingredient:1
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 42806-524-10 1000 CAPSULE in 1 BOTTLE (42806-524-10)
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE;ORAL 040228 ANDA Epic Pharma, LLC 42806-524 42806-524-01 100 CAPSULE in 1 BOTTLE (42806-524-01)

Summary for product number 001

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


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