Last Updated: June 25, 2026

Details for New Drug Application (NDA): 091451

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NDA 091451 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, Ingenus Pharms Llc, Kvk Tech Inc, 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 091451

Tradename:	PHENTERMINE HYDROCHLORIDE
Applicant:	Ingenus Pharms Llc
Ingredient:	phentermine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	37.5MG
Approval Date:	Sep 21, 2012	TE:		RLD:	No

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