FDA — authorised 28 May 1996
- Application: NDA020671
- Marketing authorisation holder: SANDOZ
- Local brand name: HYCAMTIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Oral Topotecan in United States
FDA authorised Oral Topotecan on 28 May 1996
Marketing authorisation
Other Oncology approved in United States
Frequently asked questions
Is Oral Topotecan approved in United States?
Yes. FDA authorised it on 28 May 1996.
Who is the marketing authorisation holder for Oral Topotecan in United States?
SANDOZ holds the US marketing authorisation.