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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL2300209 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Import Drug Application 2023-09-09 F Hoffmann-La Roche Ltd(Switzerland);Roche (China) Holding Ltd view
JXHB2300010 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2023-01-11 F Hoffmann-La Roche AG;F Hoffmann-La Roche Ltd(Switzerland) view
JXHB2300001 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2023-01-05 F Hoffmann-La Roche Ltd(Switzerland) view
JXHB2200069 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2022-06-09 F Hoffmann-La Roche Ltd(Switzerland) view
JXHB2200034 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2022-03-16 F Hoffmann-La Roche Ltd(Switzerland) view
JTH2200048 GDC-9545 giredestrant Active ingredient Chemical Drugs Disposable Import Drug Application 2022-03-09 F Hoffmann-La Roche AG;F Hoffmann-La Roche Ltd(Switzerland);Roche (China) Holding Ltd view
JXHL2200052 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Import Drug Application 2022-03-07 F Hoffmann-La Roche Ltd(Switzerland);Roche (China) Holding Ltd view
JXHB2101105 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2021-11-26 F Hoffmann-La Roche Ltd(Switzerland) view
JXHB2101071 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2021-09-13 F Hoffmann-La Roche Ltd(Switzerland) view
JXHL2101017 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Import Drug Application 2021-05-13 F Hoffmann-La Roche Ltd(Switzerland);Roche (China) Holding Ltd view
JXHB2101002 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2021-04-01 F Hoffmann-La Roche Ltd(Switzerland) view
JXHB2000048 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Supplementary Application 2020-11-14 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-11-13 view
JXHL2000248 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Import Drug Application 2020-09-17 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-09-16 view
JXHL2000217 GDC-9545 giredestrant Active ingredient Chemical Drugs(1) Import Drug Application 2020-07-28 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-07-27 view