FDA — authorised 17 June 1969
- Application: NDA016793
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 rhTPO in United States
FDA authorised rhTPO on 17 June 1969 · 6 US adverse-event reports
Marketing authorisations
FDA — authorised 2 August 1989
- Application: ANDA071471
- Marketing authorisation holder: HIKMA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 1989
- Application: ANDA071472
- Marketing authorisation holder: HIKMA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 June 1990
- Application: ANDA071868
- Marketing authorisation holder: HOSPIRA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA072168
- Marketing authorisation holder: HOSPIRA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 1994
- Application: ANDA072945
- Marketing authorisation holder: HOSPIRA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1994
- Application: ANDA074245
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 November 1999
- Application: ANDA075383
- Marketing authorisation holder: HOSPIRA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 January 2004
- Application: ANDA076512
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2011
- Application: ANDA200916
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2011
- Application: ANDA200915
- Marketing authorisation holder: RISING
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2011
- Application: ANDA200914
- Marketing authorisation holder: RISING
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 2012
- Application: ANDA201784
- Marketing authorisation holder: RISING
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 January 2014
- Application: NDA205582
- Marketing authorisation holder: SUN PHARM
- Local brand name: DECITABINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 28 August 2014
- Application: ANDA202969
- Marketing authorisation holder: SANDOZ
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 February 2017
- Application: ANDA203475
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 May 2017
- Application: ANDA204607
- Marketing authorisation holder: PHARMASCIENCE INC
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 September 2017
- Application: ANDA206033
- Marketing authorisation holder: CHEMI SPA
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA208601
- Marketing authorisation holder: CIPLA
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 March 2018
- Application: ANDA207100
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 July 2018
- Application: ANDA205696
- Marketing authorisation holder: MEITHEAL
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 2018
- Application: ANDA210756
- Marketing authorisation holder: LUPIN
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 April 2019
- Application: ANDA209056
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 August 2019
- Application: ANDA212265
- Marketing authorisation holder: MSN
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 September 2019
- Application: ANDA210984
- Marketing authorisation holder: NOVAST LABS
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 November 2020
- Application: ANDA205539
- Marketing authorisation holder: GLAND
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2020
- Application: ANDA212117
- Marketing authorisation holder: NIVAGEN PHARMS INC
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 12 April 2021
- Application: ANDA212826
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 2 July 2021
- Application: ANDA212959
- Marketing authorisation holder: MEITHEAL
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 20 September 2021
- Application: ANDA214569
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 November 2021
- Application: ANDA214486
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 February 2022
- Application: ANDA208485
- Marketing authorisation holder: MEITHEAL
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2022
- Application: ANDA213472
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA215355
- Marketing authorisation holder: HETERO LABS LTD VI
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 December 2025
- Application: ANDA217814
- Marketing authorisation holder: RELIANCE LIFE SCI
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA071249
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CYTARABINE
- Indication: Injectable — Injection
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 6
Most-reported reactions
- Drug Ineffective — 1 report (16.67%)
- Exposure During Pregnancy — 1 report (16.67%)
- Foetal Exposure During Pregnancy — 1 report (16.67%)
- Hepatic Artery Thrombosis — 1 report (16.67%)
- Premature Baby — 1 report (16.67%)
- Premature Delivery — 1 report (16.67%)
rhTPO 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 rhTPO approved in United States?
Yes. FDA authorised it on 17 June 1969; FDA authorised it on 2 August 1989; FDA authorised it on 2 August 1989.
Who is the marketing authorisation holder for rhTPO in United States?
TEVA PARENTERAL holds the US marketing authorisation.