Active substance
Capreomycin
- US FDA 3
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CAPASTAT SULFATE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | EPIC PHARMA LLC | Discontinued | 2 Jun 1971 |
| CAPREOMYCIN SULFATE | EQ 1GM BASE/VIAL | injectable · injection | PHARMOBEDIENT | Discontinued | 27 Nov 2017 |
| CAPREOMYCIN SULFATE | EQ 1GM BASE/VIAL | injectable · injection | HISUN PHARM HANGZHOU | Discontinued | 18 Oct 2018 |
Safety signals and safety-related labeling changes
- US FDA 17 Jan 2023 CAPASTAT SULFATE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions
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.