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序號 商品名 申請?zhí)?/th> 產(chǎn)品號 申請類型 活性成分 劑型 規(guī)格 參比藥物 參比標準 申請?zhí)柵鷾嗜掌?/th> 產(chǎn)品號批準日期 申請人 市場狀態(tài)
1 ACETAZOLAMIDE 212089 1 ANDA ACETAZOLAMIDE TABLET;ORAL 125MG 2025-05-30 2025-05-30 AUROBINDO PHARMA LTD Prescription
2 ACETAZOLAMIDE 212089 2 ANDA ACETAZOLAMIDE TABLET;ORAL 250MG 2025-05-30 2025-05-30 AUROBINDO PHARMA LTD Prescription
3 PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 216830 1 NDA PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 20MG/250ML (0.08MG/ML) 2025-05-30 2025-05-30 SINTETICA SA Prescription
4 ROCURONIUM BROMIDE 219674 1 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) 2025-05-29 2025-05-29 MANKIND PHARMA Prescription
5 ROCURONIUM BROMIDE 219674 2 ANDA ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) 2025-05-29 2025-05-29 MANKIND PHARMA Prescription
6 METHYLNALTREXONE BROMIDE 208592 1 ANDA METHYLNALTREXONE BROMIDE SOLUTION;SUBCUTANEOUS 12MG/0.6ML (12MG/0.6ML) 2025-05-28 2025-05-28 MYLAN LABS LTD Prescription
7 TRYPTYR 217370 1 NDA ACOLTREMON SOLUTION/DROPS;OPHTHALMIC 3e-005 2025-05-28 2025-05-28 ALCON LABS INC Prescription
8 KHINDIVI 218980 1 NDA HYDROCORTISONE SOLUTION;ORAL 1MG/ML 2025-05-28 2025-05-28 ETON Prescription
9 MAGNESIUM SULFATE 219777 1 ANDA MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 1GM/2ML (500MG/ML) 2025-05-28 2025-05-28 ASPIRO Prescription
10 MAGNESIUM SULFATE 219777 2 ANDA MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 5GM/10ML (500MG/ML) 2025-05-28 2025-05-28 ASPIRO Prescription
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