FDA — authorised 15 November 2010
- Application: ANDA079183
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Gemcitabine Hydrochloride Injection in United States
FDA authorised Gemcitabine Hydrochloride Injection on 15 November 2010 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 25 January 2011
- Application: ANDA077983
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 May 2011
- Application: ANDA090799
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 May 2011
- Application: ANDA090242
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2011
- Application: ANDA200145
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2011
- Application: ANDA091365
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2011
- Application: ANDA078339
- Marketing authorisation holder: HOSPIRA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2011
- Application: ANDA091594
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2011
- Application: ANDA079160
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2011
- Application: ANDA078433
- Marketing authorisation holder: SUN PHARM
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 2011
- Application: NDA200795
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 September 2012
- Application: ANDA090663
- Marketing authorisation holder: HAMELN RDS GMBH
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 2013
- Application: ANDA091597
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 2013
- Application: ANDA202997
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 2013
- Application: ANDA202485
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 2013
- Application: ANDA202031
- Marketing authorisation holder: AM REGENT
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 January 2016
- Application: ANDA204520
- Marketing authorisation holder: GLAND
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 April 2016
- Application: ANDA204549
- Marketing authorisation holder: ACTAVIS INC
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 May 2017
- Application: ANDA206776
- Marketing authorisation holder: APOTEX
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 December 2017
- Application: ANDA205242
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2018
- Application: NDA208313
- Marketing authorisation holder: SUN PHARM
- Local brand name: INFUGEM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 20 July 2018
- Application: ANDA209077
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 February 2019
- Application: ANDA210383
- Marketing authorisation holder: NOVAST LABS
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA207575
- Marketing authorisation holder: SHILPA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 October 2019
- Application: ANDA210991
- Marketing authorisation holder: SHILPA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 December 2020
- Application: ANDA212129
- Marketing authorisation holder: MEITHEAL
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 March 2023
- Application: ANDA213175
- Marketing authorisation holder: HIKMA
- Local brand name: GEMCITABINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2025
- Application: NDA219920
- Marketing authorisation holder: AVYXA HOLDINGS
- Local brand name: AVGEMSI
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 9 September 2025
- Application: NDA219683
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: INLEXZO
- Indication: SYSTEM — INTRAVESICAL
- 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: 23 April 2025 – 23 April 2026
- Total reports: 10
Most-reported reactions
- Anaemia — 1 report (10%)
- Cough — 1 report (10%)
- Dehydration — 1 report (10%)
- Dyspnoea — 1 report (10%)
- Fatigue — 1 report (10%)
- Generalised Oedema — 1 report (10%)
- Hypoalbuminaemia — 1 report (10%)
- Myalgia — 1 report (10%)
- Nausea — 1 report (10%)
- Neutrophil Count Decreased — 1 report (10%)
Other Oncology approved in United States
Frequently asked questions
Is Gemcitabine Hydrochloride Injection approved in United States?
Yes. FDA authorised it on 15 November 2010; FDA authorised it on 25 January 2011; FDA authorised it on 16 May 2011.
Who is the marketing authorisation holder for Gemcitabine Hydrochloride Injection in United States?
HOSPIRA INC holds the US marketing authorisation.