FDA — authorised 29 September 1952
- Marketing authorisation holder: SANDOZ
- Status: approved
🇺🇸 Isoniazid in United States
FDA authorised Isoniazid on 29 September 1952
Marketing authorisations
FDA — authorised 24 August 1972
- Application: ANDA080936
- Marketing authorisation holder: GENUS
- Status: approved
FDA — authorised 7 September 1983
- Application: ANDA080937
- Marketing authorisation holder: GENUS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 31 July 1998
- Application: ANDA081118
- Marketing authorisation holder: CHARTWELL RX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 September 1999
- Application: ANDA088235
- Marketing authorisation holder: CMP PHARMA INC
- Indication: Labeling
- Status: approved
FDA — authorised 5 July 2005
- Application: ANDA040648
- Marketing authorisation holder: SANDOZ
- Status: approved
Isoniazid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Isoniazid approved in United States?
Yes. FDA authorised it on 29 September 1952; FDA authorised it on 24 August 1972; FDA authorised it on 7 September 1983.
Who is the marketing authorisation holder for Isoniazid in United States?
SANDOZ holds the US marketing authorisation.