FDA — authorised 16 July 1999
- Application: ANDA074735
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Albumin-Bound Paclitaxel in United States
FDA authorised Albumin-Bound Paclitaxel on 16 July 1999
Marketing authorisations
FDA — authorised 16 May 2000
- Application: ANDA074656
- Marketing authorisation holder: PHARMACHEMIE BV
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 November 2000
- Application: ANDA075036
- Marketing authorisation holder: HIKMA
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 November 2000
- Application: ANDA074713
- Marketing authorisation holder: BEDFORD
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 August 2015
- Application: ANDA206774
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 2017
- Application: ANDA207323
- Marketing authorisation holder: GLAND
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA218868
- Marketing authorisation holder: QILU
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Albumin-Bound Paclitaxel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Albumin-Bound Paclitaxel approved in United States?
Yes. FDA authorised it on 16 July 1999; FDA authorised it on 16 May 2000; FDA authorised it on 7 November 2000.
Who is the marketing authorisation holder for Albumin-Bound Paclitaxel in United States?
FRESENIUS KABI USA holds the US marketing authorisation.