美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ATROPINE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ATROPINE SULFATE 212868 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.25MG/5ML (0.05MG/ML) No No 2021/07/26 2021/07/26 ACCORD HLTHCARE Prescription
ATROPINE SULFATE 212868 002 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) No No 2021/07/26 2021/07/26 ACCORD HLTHCARE Prescription
ATROPINE SULFATE 212868 003 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) No No 2021/07/26 2021/07/26 ACCORD HLTHCARE Prescription
ATROPINE SULFATE 215624 001 ANDA ATROPINE SULFATE SOLUTION/DROPS;OPHTHALMIC 1% No No 2021/11/26 2021/11/26 APOTEX Prescription
ATROPINE SULFATE 213561 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL 8MG/20ML (0.4MG/ML) No No 2021/12/01 2021/12/01 HIKMA Prescription
ATROPINE SULFATE 215342 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) No No 2022/01/26 2022/01/26 AMNEAL Prescription
ATROPINE SULFATE 215342 002 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) No No 2022/01/26 2023/10/25 AMNEAL Prescription
ATROPINE SULFATE 213581 001 NDA ATROPINE SULFATE SOLUTION/DROPS;OPHTHALMIC 1% Yes Yes 2022/03/15 2022/03/15 BAUSCH AND LOMB INC Prescription
ATROPINE SULFATE 216120 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.4MG/ML (0.4MG/ML) No No 2022/05/26 2022/05/26 AM REGENT Prescription
ATROPINE SULFATE 216120 002 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/ML (1MG/ML) No No 2022/05/26 2022/05/26 AM REGENT Prescription
ATROPINE SULFATE 214752 001 ANDA ATROPINE SULFATE SOLUTION/DROPS;OPHTHALMIC 1% No Yes 2022/07/14 2022/07/14 AMNEAL Prescription
ATROPINE SULFATE 214970 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) No No 2022/11/04 2022/11/04 MEDEFIL INC Prescription
ATROPINE SULFATE 218148 001 ANDA ATROPINE SULFATE SOLUTION/DROPS;OPHTHALMIC 1% No No 2024/01/08 2024/01/08 MANKIND PHARMA Prescription
ATROPINE SULFATE 217791 001 ANDA ATROPINE SULFATE SOLUTION/DROPS;OPHTHALMIC 1% No No 2024/04/29 2024/04/29 SOMERSET Prescription
ATROPINE SULFATE 215618 001 ANDA ATROPINE SULFATE SOLUTION/DROPS;OPHTHALMIC 1% No No 2024/07/01 2024/07/01 SOMERSET THERAPS LLC Prescription
ATROPINE SULFATE 215969 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.4MG/ML (0.4MG/ML) No No 2024/07/03 2024/07/03 SOMERSET THERAPS LLC Prescription
ATROPINE SULFATE 215969 002 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/ML (1MG/ML) No No 2024/07/03 2024/07/03 SOMERSET THERAPS LLC Prescription
ATROPINE SULFATE 215005 001 ANDA ATROPINE SULFATE SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL 8MG/20ML (0.4MG/ML) No No 2024/11/29 2024/11/29 SOMERSET THERAPS LLC Prescription
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