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Last Updated: February 25, 2021

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Details for New Drug Application (NDA): 040190

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NDA 040190 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, Kvk Tech, Lannett, Lannett Co Inc, Nuvo Pharm, Sandoz, Sun Pharm Industries, Teva, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Actavis Elizabeth, Kvk Tech Inc, Novast Labs, Polygen Pharms, Prinston Inc, Sandoz Inc, and Sun Pharm Inds Inc, and is included in eighty-seven NDAs. It is available from thirty 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-one suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
Summary for 040190
Tradename:PHENTERMINE HYDROCHLORIDE
Applicant:Elite Labs Inc
Ingredient:phentermine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040190
Suppliers and Packaging for NDA: 040190
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 040190 ANDA Epic Pharma, LLC 42806-810 42806-810-01 100 TABLET in 1 BOTTLE (42806-810-01)
PHENTERMINE HYDROCHLORIDE phentermine hydrochloride TABLET;ORAL 040190 ANDA Epic Pharma, LLC 42806-810 42806-810-10 1000 TABLET in 1 BOTTLE (42806-810-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength37.5MG
Approval Date:May 30, 1997TE:AARLD:No

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