Products ANDA number Approval Holder
1 Irinotican Hydrochloride Injection-40mg/2mL, 100mg/5mL 090675 2011.12.16 Jiangsu Hengrui Medicine Co., Ltd.
2 Gabapentin Capsules-100mg, 300mg, 400mg 091008 2013.01.18-Tentative
2017.10.26 -Final
Jiangsu Hengrui Medicine Co., Ltd.
3 Letrozole Tablets-2.5mg 202716 2013.05.16 Jiangsu Hengrui Medicine Co., Ltd.
4 Docetaxel Injection-20mg/0.5mL, Two vial Formulation 203170 2017.02.15 Jiangsu Hengrui Medicine Co., Ltd.
5 Sevoflurane, Liquid for Inhalation, 100%, 250mL 203793 2015.11.03 Shanghai Hengrui Pharmaceutical Co., Ltd.
6 Oxaliplatin Injection-50mg/10mL, 100mg/20mL 203869 2014.06.18 Jiangsu Hengrui Medicine Co., Ltd.
7 Cyclophosphamide for Injection- 500 mg, 1 gram, 2 gram 204555 2014.10.31 Jiangsu Hengrui Medicine Co., Ltd.
8 Cisatracurium Besylate Injection-10mg/5mL 204960 2017.01.27 Jiangsu Hengrui Medicine Co., Ltd.
9 Fondaparinux Sodium Injection-2.5mg/0.5mL, 5mg/0.4mL,7.5mg/0.6mL, 10mg/0.8mL 206812 2018.05.15 Jiangsu Hengrui Medicine Co., Ltd.
10 Docetaxel Injection-20mg/1mL, 80mg/4mL, 160mg/8mL, One vial Formulation 207252 2017.08.09 Jiangsu Hengrui Medicine Co., Ltd.
11 Tolvaptan Tablets-15mg, 30mg 207255 2018.07.27-Tentative Jiangsu Hengrui Medicine Co., Ltd.
12 Desflurane, Liquid for Inhalation, 240mL 208234 2018.02.26 Shanghai Hengrui Pharmaceutical Co., Ltd.
13 Dexmedetomidine Hydrochloride Injection- 200mcg/2mL 209065 2017.09.19 Jiangsu Hengrui Medicine Co., Ltd.
14 Thiotepa for Injection-15mg/vial 209150 2018.05.04 Jiangsu Hengrui Medicine Co., Ltd.
15 Cisatracurium Besylate Injection-20mg/10mL, multi-dose vial with Preservative 209334 2017.08.30 Jiangsu Hengrui Medicine Co., Ltd.
16 Cisatracurium Besylate Injection-200mg/20mL, PAS 204960/S-003 2017.09.19 Jiangsu Hengrui Medicine Co., Ltd.