Active substance
Estazolam
- US FDA 4
- US price lines 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ESTAZOLAM | 1MG; 2MG | tablet · oral | NOVITIUM PHARMA | Prescription | 3 Jul 1997 |
| ESTAZOLAM | 1MG; 2MG | tablet · oral | DR REDDYS LABS SA | Prescription | 10 Jul 1997 |
| ESTAZOLAM | 1MG; 2MG | tablet · oral | WATSON LABS | Prescription | 19 Aug 1997 |
| PROSOM | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ABBOTT | Discontinued | 26 Dec 1990 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ESTAZOLAM 1 MG TABLET | $0.88416 | per EA | 23 Sep 2026 |
| US NADAC | ESTAZOLAM 2 MG TABLET | $0.83942 | 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
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No
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.