Is Cycloserine approved by the US FDA?

Drugs@FDA lists 1 application product line for Cycloserine, including SEROMYCIN (Prescription).

Is Cycloserine authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Cycloserine, including CYCLOSERINE 250MG HARD CAPSULES.

Is Cycloserine on the WHO Model List of Essential Medicines?

Yes — 6.2.5. Antituberculosis medicines (core list): Multi-drug resistant Mycobacterium tuberculosis.

Active substance

Cycloserine

US FDA 1
UK MHRA 1
WHO EML 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
SEROMYCIN	250MG	capsule · oral	SANALUZ	Prescription	29 Jun 1964

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
CYCLOSERINE 250MG HARD CAPSULES	PL 45043/0109	NEON HEALTHCARE LIMITED	POM

WHO WHO Model List of Essential Medicines (2025)

6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis
Oral > Solid > dosage form: 250 mg; 125 mg (EMLc)

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.