美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ACETYLCYSTEINE"
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
ACETYLCYSTEINE 071740 001 ANDA ACETYLCYSTEINE Solution; Inhalation, Oral 10% No No -- -- QUAD PHARMS Discontinued
ACETYLCYSTEINE 071741 001 ANDA ACETYLCYSTEINE Solution; Inhalation, Oral 20% No No -- -- QUAD PHARMS Discontinued
ACETYLCYSTEINE 072323 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 10% No No 1992/04/30 1992/04/30 ROXANE Discontinued
ACETYLCYSTEINE 072324 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 20% No No 1992/04/30 1992/04/30 ROXANE Discontinued
ACETYLCYSTEINE 072621 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 10% No No 1992/09/30 1992/09/30 ROXANE Discontinued
ACETYLCYSTEINE 072622 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 20% No No 1992/09/30 1992/09/30 ROXANE Discontinued
ACETYLCYSTEINE 073664 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 10% No No 1994/08/30 1994/08/30 HOSPIRA Prescription
ACETYLCYSTEINE 074037 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 20% No No 1994/08/30 1994/08/30 HOSPIRA Prescription
ACETYLCYSTEINE 072489 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 10% No Yes 1995/07/28 1995/07/28 AM REGENT Prescription
ACETYLCYSTEINE 072547 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 20% No Yes 1995/07/28 1995/07/28 AM REGENT Prescription
ACETYLCYSTEINE 071364 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 10% No No 2007/11/20 1989/05/01 HOSPIRA Discontinued
ACETYLCYSTEINE 071365 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 20% No No 2007/11/20 1989/05/01 HOSPIRA Discontinued
ACETYLCYSTEINE 203853 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 20% No No 2012/06/21 2012/06/21 ALVOGEN Prescription
ACETYLCYSTEINE 200644 001 ANDA ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) No No 2012/11/07 2012/11/07 FRESENIUS KABI USA Prescription
ACETYLCYSTEINE 204674 001 ANDA ACETYLCYSTEINE SOLUTION;INHALATION, ORAL 10% No No 2014/02/11 2014/02/11 ALVOGEN Prescription
ACETYLCYSTEINE 203173 001 ANDA ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) No No 2015/03/24 2015/03/24 RISING Prescription
ACETYLCYSTEINE 203624 001 ANDA ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) No No 2015/11/17 (TA) -- RISING None (Tentative Approval)
ACETYLCYSTEINE 207358 001 ANDA ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) No No 2016/02/29 2016/02/29 EUGIA PHARMA Prescription
ACETYLCYSTEINE 091684 001 ANDA ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) No No 2017/10/31 2017/10/31 SAGENT PHARMS INC Prescription
ACETYLCYSTEINE 208166 001 ANDA ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) No No 2018/07/20 2018/07/20 ZYDUS PHARMS Prescription
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