FDA — authorised 24 March 1976
- Status: approved
🇺🇸 Tolectin 600 in United States
FDA authorised Tolectin 600 on 24 March 1976
Marketing authorisations
FDA — authorised 24 March 1976
- Application: NDA017628
- Marketing authorisation holder: ORTHO MCNEIL JANSSEN
- Local brand name: TOLECTIN 600
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 1993
- Application: ANDA073393
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 9 May 2016
- Application: ANDA074473
- Marketing authorisation holder: RISING
- Indication: Labeling
- Status: approved
Tolectin 600 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Tolectin 600 approved in United States?
Yes. FDA authorised it on 24 March 1976; FDA authorised it on 24 March 1976; FDA authorised it on 27 May 1993.
Who is the marketing authorisation holder for Tolectin 600 in United States?
Marketing authorisation holder not available in our data.