美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PROMETHAZINE HYDROCHLORIDE"
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
PROMETHAZINE HYDROCHLORIDE 040372 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2000/06/08 2000/06/08 HOSPIRA Discontinued
PROMETHAZINE HYDROCHLORIDE 040428 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No Yes 2002/02/05 2002/02/05 COSETTE Prescription
PROMETHAZINE HYDROCHLORIDE 040428 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2002/02/05 2003/03/31 COSETTE Prescription
PROMETHAZINE HYDROCHLORIDE 040454 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/08/22 2002/08/22 TEVA PHARMS USA Discontinued
PROMETHAZINE HYDROCHLORIDE 040454 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/08/22 2002/08/22 TEVA PHARMS USA Discontinued
PROMETHAZINE HYDROCHLORIDE 040471 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2002/11/21 2002/11/21 MYLAN INSTITUTIONAL Discontinued
PROMETHAZINE HYDROCHLORIDE 040449 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 50MG No No 2003/02/27 2003/02/27 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040515 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2003/03/19 2003/03/19 AM REGENT Discontinued
PROMETHAZINE HYDROCHLORIDE 040504 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2003/04/11 2003/04/11 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040504 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No No 2003/04/11 2003/04/11 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040479 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2003/06/24 2003/06/24 WATSON LABS INC Discontinued
PROMETHAZINE HYDROCHLORIDE 040479 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No No 2003/06/24 2003/06/24 WATSON LABS INC Discontinued
PROMETHAZINE HYDROCHLORIDE 040500 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2003/06/30 2003/06/30 PADAGIS ISRAEL Prescription
PROMETHAZINE HYDROCHLORIDE 040500 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No No 2003/06/30 2003/06/30 PADAGIS ISRAEL Prescription
PROMETHAZINE HYDROCHLORIDE 040524 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2004/03/17 2004/03/17 BEDFORD LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 040524 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2004/03/17 2004/03/17 BEDFORD LABS Discontinued
PROMETHAZINE HYDROCHLORIDE 040558 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2004/07/01 2004/07/01 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040558 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 2004/07/01 2004/07/01 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040558 003 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No 2004/07/01 2004/07/01 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040596 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No 2005/11/18 2005/11/18 ZYDUS PHARMS USA Prescription
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