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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 083923

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NDA 083923 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, Merro Pharm Usa, Novast Labs, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, and Actavis Labs Fl Inc, and is included in eighty-eight NDAs. It is available from thirty-two 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. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for 083923

Tradename:	PHENTERMINE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	phentermine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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