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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
Semaglutide
司美格鲁肽
NDA
218316
Tablet;Oral
Novo
2025-12-22
Dextromethorphan Hydrobromide; Guaifenesin; Naproxen Sodium
NDA
217338
Tablet, Extended Release;Oral
Rb Hlth
2025-12-22
Suvorexant
苏沃雷生
ANDA
219386
Tablet
Hetero Labs Ltd Unit Iii
2025-12-22
Nerandomilast
NDA
220449
Tablet;Oral
Boehringer Ingelheim
2025-12-19
Decitabine
地西他滨
ANDA
217814
Injectable;Intravenous
Reliance Life Sci
2025-12-19
Aficamten
阿夫凯泰
NDA
219083
Tablet;Oral
Cytokinetics
2025-12-19
Denosumab-mobz
BLA
761456
Injectable;Subcutaneous
Amneal Pharms Llc
2025-12-19
Denosumab-mobz
BLA
761457
Injectable;Subcutaneous
Amneal Pharms Llc
2025-12-19
Apixaban
阿哌沙班
ANDA
218519
Tablet
Fosun Wanbang (jiangsu) Pharmaceutical Group Co.,
2025-12-19
Lasmiditan
拉米地坦
ANDA
219669
Tablet
Humanwell Pharmaceutical Us Inc
2025-12-19
Amphetamine
苯丙胺
ANDA
219800
Tablet, Orally Disintegrating;Oral
Granules Pharmaceuticals Inc
2025-12-19
Dapagliflozin
达格列净
ANDA
211541
Tablet;Oral
Teva Pharms Usa Inc
2025-12-18
Tenofovir Disoproxil Fumarate
富马酸替诺福韦二吡呋酯
ANDA
206157
Tablet;Oral
Micro Labs
2025-12-18
Haloperidol
氟哌啶醇
ANDA
218162
Tablet;Oral
Creekwood Pharms
2025-12-18
Nitroglycerin
硝酸甘油
ANDA
218756
Ointment;Intra-anal
Solaris Pharma Corp
2025-12-18
Buprenorphine Hydrochloride
盐酸丁丙诺啡
ANDA
219401
Tablet;Sublingual
Ascent Pharms Inc
2025-12-18
Ranibizumab-leyk
BLA
761473
Injection
Formycon Ag
2025-12-18
Travoprost
曲伏前列素
ANDA
214687
Solution/drops;Ophthalmic
Alembic
2025-12-17
Bortezomib
硼替佐米
ANDA
216528
Injectable;Intravenous, Subcutaneous
Shuangcheng
2025-12-17
Latanoprost
拉坦前列素
ANDA
220360
Solution/drops;Ophthalmic
Mankind Pharma
2025-12-17
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