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Last Updated: December 11, 2025

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, 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, Aurobindo Pharma Ltd, Kvk Tech Inc, Novast Labs, Prinston Inc, Puracap Labs Blu, Sandoz Inc, Sun Pharm Inds Inc, Actavis Labs Fl Inc, and Dr Reddys Labs Sa, and is included in eighty-nine NDAs. It is available from twenty-seven suppliers. Additional details are available on the PHENTERMINE HYDROCHLORIDE profile page.

The generic ingredient in PHENTERMINE HYDROCHLORIDE is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for 040228

Tradename:	PHENTERMINE HYDROCHLORIDE
Applicant:	Elite Labs Inc
Ingredient:	phentermine hydrochloride
Patents:	0

Pharmacology for NDA: 040228

Physiological Effect	Appetite Suppression Increased Sympathetic Activity

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	37.5MG
Approval Date:	Jun 19, 1997	TE:		RLD:	No

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