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商品名
活性成分
中文名称
申请类型
申请号
剂型
申请机构
批准日期
Macitentan
马昔腾坦
ANDA
211123
Tablet;Oral
Sun Pharm
2025-08-26
Dasatinib
达沙替尼
ANDA
214350
Tablet;Oral
Lupin
2025-08-25
Sodium Bicarbonate
碳酸氢钠
ANDA
206688
Injectable;Injection
Fresenius Kabi Usa
2025-08-25
Leuprolide Mseylate
NDA
219745
Injection, Emulsion
Foresee Pharmaceuticals Co Ltd
2025-08-25
Tenofovir Alafenamide Fumarate
富马酸替诺福韦艾拉酚胺
ANDA
214030
Tablet;Oral
Laurus Labs Ltd
2025-08-22
Penciclovir
喷昔洛韦
ANDA
214100
Cream;Topical
Amneal
2025-08-22
Diphenhydramine Hydrochloride
盐酸苯海拉明
ANDA
219845
Injectable;Injection
Micro Labs
2025-08-22
Naloxone Hydrochloride
盐酸纳洛酮
ANDA
214211
Injectable;Injection
Sterinova Inc
2025-08-21
Donidalorsen Injection
NDA
219407
Injection;Solution
Ionis Pharms Inc
2025-08-21
Macitentan
马昔腾坦
ANDA
211136
Tablet;Oral
Msn
2025-08-20
Hydrochlorothiazide; Olmesartan Medoxomil
氢氯噻嗪;奥美沙坦酯
ANDA
214427
Tablet;Oral
Zhejiang Nuode
2025-08-20
Nicardipine Hydrochloride
盐酸尼卡地平
ANDA
216819
Injectable;Injection
Nanjing King-friend
2025-08-20
Rilpivirine
利匹韦林
ANDA
218798
Tablet
Somerset Therapeutics, Llc
2025-08-20
Dapagliflozin, Metformin Hydrochloride
ANDA
211559
Tablet, Extended Release
Macleods Pharmaceuticals Ltd
2025-08-19
Paclitaxel
紫杉醇
ANDA
217877
Powder;Intravenous
Mylan
2025-08-19
Tranexamic Acid
氨甲环酸
ANDA
219123
Tablet;Oral
Bionpharma
2025-08-19
Tofacitinib Citrate
枸橼酸托法替布
ANDA
219542
Tablet, Extended Release;Oral
Ajanta Pharma Ltd
2025-08-19
Macitentan
马昔腾坦
ANDA
211128
Tablet;Oral
Alembic
2025-08-18
Degarelix Acetate
醋酸地加瑞克
ANDA
215791
Njection, Powder, Lyophilized, For Solution
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
2025-08-18
Articaine Hydrochloride
盐酸阿替卡因
NDA
218643
Solution/drops;Ophthalmic
Am Genomics
2025-08-15
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