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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 040083

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NDA 040083 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-six 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 040083

Tradename:	PHENTERMINE HYDROCHLORIDE
Applicant:	Tg United Inc
Ingredient:	phentermine hydrochloride
Patents:	0

Suppliers and Packaging for NDA: 040083

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	040083	NDA	Maco Productions	14498-001	14498-001-01	1 KIT in 1 KIT (14498-001-01)
PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	040083	NDA	Maco Productions	14498-002	14498-002-01	1 KIT in 1 KIT (14498-002-01) * 70 mL in 1 BAG * 110 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Mar 7, 1997	TE:		RLD:	No

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