Regulatory PathRegulatory requirements compared

Active substance

Phentermine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ADIPEX-P37.5MGtablet · oralTEVAPrescription22 Oct 1980
PHENTERMINE HYDROCHLORIDE30MG; 15MGcapsule · oralSANDOZPrescription12 Jun 1981
PHENTERMINE HYDROCHLORIDE30MGcapsule · oralSANDOZPrescription20 Jul 1983
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralELITE LABS INCPrescription30 May 1997
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralPRINSTON INCPrescription4 Jan 2002
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralSUN PHARM INDUSTRIESPrescription23 Oct 2003
PHENTERMINE HYDROCHLORIDE30MGcapsule · oralKVK TECHPrescription21 Mar 2008
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralKVK TECHPrescription31 Mar 2008
PHENTERMINE HYDROCHLORIDE30MG; 15MGcapsule · oralKVK TECHPrescription31 Mar 2008
PHENTERMINE HYDROCHLORIDE37.5MGcapsule · oralKVK TECHPrescription24 Apr 2008
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralELITE LABSPrescription31 Jan 2011
PHENTERMINE HYDROCHLORIDE15MG; 30MGcapsule · oralELITE LABSPrescription28 Sep 2012
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralAUROBINDO PHARMA LTDPrescription6 Aug 2014
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralNUVO PHARMPrescription25 Sep 2014
PHENTERMINE HYDROCHLORIDE37.5MGcapsule · oralNUVO PHARMPrescription25 Sep 2014
PHENTERMINE HYDROCHLORIDE15MG; 30MGcapsule · oralNUVO PHARMPrescription5 Dec 2014
LOMAIRA8MGtablet · oralAVANTHI INCPrescription12 Sep 2016
PHENTERMINE HYDROCHLORIDE15MG; 30MGcapsule · oralAUROLIFE PHARMA LLCPrescription9 Nov 2016
PHENTERMINE HYDROCHLORIDE37.5MGtablet · oralPURACAP LABS BLUPrescription18 Nov 2016
PHENTERMINE HYDROCHLORIDE8MGtablet · oralKVK TECH INCPrescription17 Mar 2017
PHENTERMINE HYDROCHLORIDE15MG; 30MG; 37.5MGtablet, orally disintegrating · oralZYDUS PHARMSPrescription28 Jun 2017
FASTIN30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralGLAXOSMITHKLINEDiscontinued14 Aug 1973
TORA8MGtablet · oralSOLVAYDiscontinued24 Feb 1976
PHENTERMINE HYDROCHLORIDE8MGtablet · oralCHARTWELL RXDiscontinued1 Jul 1976
PHENTERMINE HYDROCHLORIDE8MGtablet · oralCHARTWELL RXDiscontinued14 Mar 1977

75 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLOMAIRA 8 MG TABLET$0.61814per EA23 Sep 2026
US NADACPHENTERMINE 15 MG CAPSULE$0.10137per EA23 Sep 2026
US NADACPHENTERMINE 30 MG CAPSULE$0.12596per EA23 Sep 2026
US NADACPHENTERMINE 37.5 MG CAPSULE$0.1051per EA23 Sep 2026
US NADACPHENTERMINE 37.5 MG TABLET$0.07268per EA23 Sep 2026
US NADACPHENTERMINE 8 MG TABLET$0.61814per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 6 Mar 2026 QSYMIA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for phentermine →

Combinations containing Phentermine

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.