Is Phendimetrazine approved by the US FDA?

Drugs@FDA lists 97 application product lines for Phendimetrazine, including BONTRIL PDM (Prescription); PHENDIMETRAZINE TARTRATE (Prescription); PHENDIMETRAZINE TARTRATE (Prescription); PHENDIMETRAZINE TARTRATE (Prescription); PHENDIMETRAZINE TARTRATE (Prescription).

Are there safety signals or safety updates for Phendimetrazine?

US FDA: 1 entry (latest 2019-03-22).

Active substance

Phendimetrazine

US FDA 97
US price lines 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
BONTRIL PDM	35MG	tablet · oral	BAUSCH	Prescription	22 Dec 1976
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	ACERTIS PHARMS	Prescription	19 Aug 1977
PHENDIMETRAZINE TARTRATE	105MG	capsule, extended release · oral	ACERTIS PHARMS	Prescription	16 Apr 1979
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	CHARTWELL	Prescription	30 Oct 1991
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	ELITE LABS INC	Prescription	28 Jan 2008
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	KVK TECH	Prescription	31 Aug 2010
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	NUMARK	Discontinued	20 Oct 1975
MELFIAT	35MG	tablet · oral	NUMARK	Discontinued	20 Oct 1975
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	22 Jul 1976
CAM-METRAZINE	35MG	tablet · oral	CHARTWELL RX	Discontinued	28 Jul 1976
ADPHEN	35MG	tablet · oral	FERNDALE LABS	Discontinued	29 Sep 1976
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	BARR	Discontinued	11 Jan 1977
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	BARR	Discontinued	11 Jan 1977
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	BARR	Discontinued	12 Jan 1977
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	BARR	Discontinued	13 Jan 1977
CAM-METRAZINE	35MG	tablet · oral	CHARTWELL RX	Discontinued	18 Jan 1977
CAM-METRAZINE	35MG	tablet · oral	CHARTWELL RX	Discontinued	18 Jan 1977
CAM-METRAZINE	35MG	tablet · oral	CHARTWELL RX	Discontinued	18 Jan 1977
CAM-METRAZINE	35MG	tablet · oral	ABC HOLDING	Discontinued	6 May 1977
PHENAZINE-35	35MG	tablet · oral	ABC HOLDING	Discontinued	6 May 1977
DI-METREX	35MG	tablet · oral	PVT FORM	Discontinued	9 May 1977
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	IVAX PHARMS	Discontinued	11 May 1977
CAM-METRAZINE	35MG	tablet · oral	CAMALL	Discontinued	11 May 1977
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	IVAX PHARMS	Discontinued	18 May 1977
PHENDIMETRAZINE TARTRATE	35MG	tablet · oral	KV PHARM	Discontinued	2 Jun 1977

72 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PHENDIMETRAZINE 35 MG TABLET	$0.13204	per EA	23 Sep 2026
US NADAC	PHENDIMETRAZINE ER 105 MG CAP	$3.38207	per EA	23 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 22 Mar 2019 PHENDIMETRAZINE TARTRATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for phendimetrazine →

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.