FDA — authorised 19 December 1978
- Marketing authorisation holder: HQ SPCLT PHARMA
- Status: approved
🇺🇸 Platinol-Aq in United States
FDA authorised Platinol-Aq on 19 December 1978
Marketing authorisations
FDA — authorised 4 April 1990
- Application: NDA018057
- Marketing authorisation holder: HQ SPCLT PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 May 2000
- Application: ANDA074656
- Marketing authorisation holder: PHARMACHEMIE BV
- 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
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA218868
- Marketing authorisation holder: QILU
- Local brand name: CISPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Platinol-Aq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Platinol-Aq approved in United States?
Yes. FDA authorised it on 19 December 1978; FDA authorised it on 4 April 1990; FDA authorised it on 16 May 2000.
Who is the marketing authorisation holder for Platinol-Aq in United States?
HQ SPCLT PHARMA holds the US marketing authorisation.