Active substance
Benzphetamine
- US FDA 10
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | KVK TECH | Prescription | 20 Jul 2010 |
| BENZPHETAMINE HYDROCHLORIDE | 25MG; 50MG | tablet · oral | CHARTWELL | Prescription | 15 Sep 2010 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | AVET LIFESCIENCES | Prescription | 27 Jan 2012 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | EPIC PHARMA LLC | Prescription | 15 Dec 2015 |
| DIDREX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | PFIZER | Discontinued | 26 Oct 1960 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | SCINOPHARM TAIWAN | Discontinued | 17 Apr 2006 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG; 25MG | tablet · oral | TEDOR PHARM | Discontinued | 30 Mar 2007 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | SPECGX LLC | Discontinued | 25 Apr 2007 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | EPIC PHARMA LLC | Discontinued | 29 Oct 2007 |
| BENZPHETAMINE HYDROCHLORIDE | 50MG | tablet · oral | IMPAX LABS | Discontinued | 18 Nov 2008 |
Safety signals and safety-related labeling changes
- US FDA 8 Apr 2020 DIDREX — safety-related labeling change
Labeling sections changed: Use in Specific Populations
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.