FDA — authorised 6 March 1964
- Status: approved
🇺🇸 Nalidixate in United States
FDA authorised Nalidixate on 6 March 1964
Marketing authorisations
FDA — authorised 6 March 1964
- Application: NDA014214
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: NEGGRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 1973
- Application: NDA017430
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: NEGGRAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 June 1988
- Application: ANDA072061
- Marketing authorisation holder: WATSON LABS
- Local brand name: NALIDIXIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 1988
- Application: ANDA071936
- Marketing authorisation holder: WATSON LABS
- Local brand name: NALIDIXIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 1988
- Application: ANDA071919
- Marketing authorisation holder: WATSON LABS
- Local brand name: NALIDIXIC ACID
- Indication: TABLET — ORAL
- Status: approved
Nalidixate 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 Nalidixate approved in United States?
Yes. FDA authorised it on 6 March 1964; FDA authorised it on 6 March 1964; FDA authorised it on 17 April 1973.
Who is the marketing authorisation holder for Nalidixate in United States?
Marketing authorisation holder not available in our data.