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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205008

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NDA 205008 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 205008

Tradename:	PHENTERMINE HYDROCHLORIDE
Applicant:	Nuvo Pharm
Ingredient:	phentermine hydrochloride
Patents:	0

Pharmacology for NDA: 205008

Physiological Effect	Appetite Suppression Increased Sympathetic Activity

Suppliers and Packaging for NDA: 205008

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	205008	ANDA	SUNRISE PHARMACEUTICAL, INC.	11534-160	11534-160-01	100 TABLET in 1 BOTTLE (11534-160-01)
PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	205008	ANDA	SUNRISE PHARMACEUTICAL, INC.	11534-160	11534-160-03	1000 TABLET in 1 BOTTLE (11534-160-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	37.5MG
Approval Date:	Sep 25, 2014	TE:	AA	RLD:	No

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