药品注册申请号:050141
申请类型:NDA (新药申请)
申请人:KING PHARMS LLC
申请人全名:KING PHARMACEUTICALS LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 BICILLIN L-A PENICILLIN G BENZATHINE INJECTABLE;INJECTION 600,000 UNITS/ML Yes Yes BC 1952/06/27 Approved Prior to Jan 1, 1982 Prescription
003 BICILLIN L-A PENICILLIN G BENZATHINE INJECTABLE;INJECTION 300,000 UNITS/ML Yes No None Approved Prior to Jan 1, 1982 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/04/30 SUPPL 237 Approval Labeling STANDARD
2018/11/07 SUPPL 236 Approval Labeling STANDARD
2017/12/07 SUPPL 235 Approval Labeling STANDARD
2015/10/13 SUPPL 233 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2014/04/25 SUPPL 232 Approval Labeling STANDARD
2012/09/06 SUPPL 231 Approval Labeling STANDARD
2009/12/18 SUPPL 226 Approval Labeling STANDARD
2005/11/17 SUPPL 224 Approval Labeling STANDARD
2002/04/29 SUPPL 219 Approval Labeling STANDARD
2002/04/29 SUPPL 218 Approval Labeling STANDARD
2002/03/01 SUPPL 215 Approval Labeling STANDARD
2001/03/23 SUPPL 217 Approval Manufacturing (CMC)
1998/01/08 SUPPL 216 Approval Manufacturing (CMC)
1993/09/22 SUPPL 213 Approval Labeling STANDARD
1993/08/31 SUPPL 212 Approval Manufacturing (CMC)
1989/05/31 SUPPL 13 Approval Labeling
1988/06/16 SUPPL 38 Approval Manufacturing (CMC)
1988/06/16 SUPPL 14 Approval Manufacturing (CMC)
1988/06/16 SUPPL 11 Approval Manufacturing (CMC)
1988/05/16 SUPPL 10 Approval Labeling
1988/05/03 SUPPL 9 Approval Manufacturing (CMC)
1987/11/17 SUPPL 7 Approval Labeling
1987/09/28 SUPPL 8 Approval Labeling
1986/12/08 SUPPL 6 Approval Labeling
1986/12/05 SUPPL 5 Approval Labeling
1985/11/18 SUPPL 4 Approval Labeling
1985/07/29 SUPPL 3 Approval Labeling
1983/07/08 SUPPL 2 Approval Labeling
1983/05/27 SUPPL 1 Approval Labeling
1982/09/16 SUPPL 211 Approval Labeling
1982/09/16 SUPPL 210 Approval Efficacy
1982/07/28 SUPPL 209 Approval Labeling
1981/12/21 SUPPL 206 Approval Labeling
1980/05/15 SUPPL 204 Approval Labeling
1978/07/27 SUPPL 203 Approval Labeling
1976/11/03 SUPPL 202 Approval Labeling
1976/06/10 SUPPL 201 Approval Labeling
1976/06/07 SUPPL 200 Approval Labeling
1976/02/10 SUPPL 199 Approval Labeling
1976/02/10 SUPPL 198 Approval Labeling
1976/02/10 SUPPL 197 Approval Labeling
1976/01/27 SUPPL 196 Approval Labeling
1975/11/05 SUPPL 195 Approval Labeling
1975/10/03 SUPPL 194 Approval Labeling
1975/07/15 SUPPL 193 Approval Labeling
1975/03/04 SUPPL 192 Approval Labeling
1975/01/09 SUPPL 191 Approval Labeling
1974/11/24 SUPPL 181 Approval Labeling
1974/11/19 SUPPL 190 Approval Labeling
1974/11/19 SUPPL 189 Approval Labeling
1974/11/19 SUPPL 188 Approval Labeling
1974/11/19 SUPPL 187 Approval Labeling
1974/10/25 SUPPL 186 Approval Labeling
1974/06/20 SUPPL 185 Approval Manufacturing (CMC)
1974/05/13 SUPPL 184 Approval Labeling
1974/04/11 SUPPL 183 Approval Labeling
1974/04/11 SUPPL 182 Approval Labeling
1973/11/27 SUPPL 180 Approval Labeling
1973/11/12 SUPPL 179 Approval Labeling
1973/10/05 SUPPL 178 Approval Labeling
1973/09/11 SUPPL 177 Approval Labeling
1973/09/11 SUPPL 176 Approval Labeling
1973/09/11 SUPPL 175 Approval Labeling
1972/09/18 SUPPL 174 Approval Labeling
1972/07/25 SUPPL 173 Approval Labeling
1972/06/16 SUPPL 172 Approval Labeling
1972/04/20 SUPPL 171 Approval Labeling
1971/11/10 SUPPL 170 Approval Labeling
1971/06/10 SUPPL 169 Approval Labeling
1971/05/18 SUPPL 168 Approval Labeling
1971/01/19 SUPPL 167 Approval Labeling
1970/11/24 SUPPL 166 Approval Labeling
1970/10/24 SUPPL 165 Approval Labeling
1970/10/19 SUPPL 164 Approval Labeling
1970/10/14 SUPPL 163 Approval Labeling
1970/09/21 SUPPL 162 Approval Labeling
1970/05/27 SUPPL 161 Approval Labeling
1970/05/25 SUPPL 160 Approval Labeling
1970/04/27 SUPPL 159 Approval Labeling
1970/04/24 SUPPL 158 Approval Labeling
1970/04/10 SUPPL 157 Approval Labeling
1970/03/27 SUPPL 156 Approval Labeling
1970/02/16 SUPPL 155 Approval Manufacturing (CMC)
1970/02/04 SUPPL 154 Approval Manufacturing (CMC)
1970/01/27 SUPPL 153 Approval Manufacturing (CMC)
1970/01/15 SUPPL 152 Approval Manufacturing (CMC)
1970/01/08 SUPPL 151 Approval Labeling
1970/01/08 SUPPL 150 Approval Labeling
1969/12/31 SUPPL 149 Approval Labeling
1969/12/03 SUPPL 148 Approval Labeling
1969/10/23 SUPPL 147 Approval Manufacturing (CMC)
1969/08/11 SUPPL 146 Approval Manufacturing (CMC)
1969/08/05 SUPPL 145 Approval Manufacturing (CMC)
1969/07/24 SUPPL 144 Approval Manufacturing (CMC)
1969/07/24 SUPPL 143 Approval Manufacturing (CMC)
1969/05/09 SUPPL 142 Approval Labeling
1969/04/10 SUPPL 141 Approval Manufacturing (CMC)
1969/02/19 SUPPL 140 Approval Labeling
1969/01/30 SUPPL 138 Approval Labeling
1969/01/03 SUPPL 136 Approval Labeling
1969/01/03 SUPPL 135 Approval Labeling
1968/12/26 SUPPL 137 Approval Labeling
1968/12/26 SUPPL 134 Approval Labeling
1968/11/26 SUPPL 133 Approval Labeling
1968/11/08 SUPPL 131 Approval Labeling
1968/11/05 SUPPL 132 Approval Labeling
1968/10/31 SUPPL 130 Approval Labeling
1968/10/09 SUPPL 129 Approval Labeling
1968/09/25 SUPPL 128 Approval Labeling
1968/09/25 SUPPL 127 Approval Labeling
1968/08/26 SUPPL 126 Approval Labeling
1968/06/05 SUPPL 125 Approval Labeling
1968/02/29 SUPPL 124 Approval Labeling
1968/02/06 SUPPL 123 Approval Labeling
1967/11/22 SUPPL 122 Approval Labeling
1967/08/11 SUPPL 120 Approval Labeling
1967/06/01 SUPPL 119 Approval Labeling
1967/05/23 SUPPL 118 Approval Labeling
1967/05/05 SUPPL 117 Approval Labeling
1967/05/01 SUPPL 116 Approval Labeling
1967/04/19 SUPPL 115 Approval Labeling
1967/04/17 SUPPL 114 Approval Labeling
1967/04/14 SUPPL 113 Approval Manufacturing (CMC)
1967/04/06 SUPPL 112 Approval Labeling
1967/03/29 SUPPL 111 Approval Labeling
1967/03/17 SUPPL 110 Approval Labeling
1967/02/24 SUPPL 109 Approval Labeling
1967/01/20 SUPPL 108 Approval Labeling
1966/07/06 SUPPL 107 Approval Labeling
1966/06/27 SUPPL 106 Approval Labeling
1966/05/16 SUPPL 105 Approval Labeling
1966/05/10 SUPPL 104 Approval Labeling
1966/03/15 SUPPL 103 Approval Labeling
1966/03/07 SUPPL 102 Approval Labeling
1966/03/02 SUPPL 101 Approval Labeling
1966/02/15 SUPPL 100 Approval Labeling
1966/02/08 SUPPL 99 Approval Labeling
1965/12/13 SUPPL 98 Approval Labeling
1965/11/03 SUPPL 97 Approval Labeling
1965/11/02 SUPPL 96 Approval Labeling
1965/10/28 SUPPL 95 Approval Labeling
1965/09/15 SUPPL 94 Approval Labeling
1965/05/06 SUPPL 93 Approval Labeling
1965/03/31 SUPPL 92 Approval Labeling
1965/03/31 SUPPL 91 Approval Labeling
1965/03/09 SUPPL 90 Approval Labeling
1965/01/22 SUPPL 89 Approval Labeling
1964/11/17 SUPPL 88 Approval Labeling
1964/10/15 SUPPL 87 Approval Labeling
1964/10/07 SUPPL 86 Approval Labeling
1964/08/13 SUPPL 85 Approval Labeling
1964/07/13 SUPPL 84 Approval Labeling
1964/04/29 SUPPL 83 Approval Labeling
1964/02/10 SUPPL 82 Approval Labeling
1963/12/26 SUPPL 81 Approval Labeling
1963/12/09 SUPPL 79 Approval Labeling
1963/11/22 SUPPL 80 Approval Labeling
1963/10/18 SUPPL 76 Approval Labeling
1963/10/16 SUPPL 78 Approval Labeling
1963/10/16 SUPPL 77 Approval Labeling
1963/09/25 SUPPL 75 Approval Labeling
1963/09/24 SUPPL 73 Approval Labeling
1963/09/18 SUPPL 74 Approval Labeling
1963/09/06 SUPPL 71 Approval Labeling
1963/09/06 SUPPL 70 Approval Labeling
1963/09/03 SUPPL 72 Approval Labeling
1963/07/31 SUPPL 69 Approval Labeling
1963/07/11 SUPPL 68 Approval Labeling
1963/07/11 SUPPL 67 Approval Labeling
1963/07/10 SUPPL 66 Approval Labeling
1963/05/28 SUPPL 65 Approval Labeling
1963/05/23 SUPPL 58 Approval Labeling
1963/04/05 SUPPL 64 Approval Labeling
1963/04/05 SUPPL 63 Approval Labeling
1963/03/23 SUPPL 57 Approval Labeling
1962/12/19 SUPPL 62 Approval Labeling
1962/12/19 SUPPL 61 Approval Labeling
1962/10/12 SUPPL 59 Approval Manufacturing (CMC)
1962/01/15 SUPPL 56 Approval Labeling
1961/08/04 SUPPL 54 Approval Labeling
1961/08/04 SUPPL 53 Approval Labeling
1961/07/10 SUPPL 52 Approval Labeling
1961/06/16 SUPPL 51 Approval Labeling
1961/06/16 SUPPL 50 Approval Labeling
1961/05/02 SUPPL 45 Approval Labeling
1961/04/05 SUPPL 49 Approval Labeling
1961/04/05 SUPPL 48 Approval Labeling
1961/03/31 SUPPL 47 Approval Labeling
1961/03/30 SUPPL 42 Approval Labeling
1961/03/24 SUPPL 46 Approval Labeling
1961/03/21 SUPPL 44 Approval Labeling
1961/03/20 SUPPL 43 Approval Labeling
1960/12/22 SUPPL 41 Approval Labeling
1960/12/22 SUPPL 39 Approval Labeling
1960/10/03 SUPPL 40 Approval Labeling
1956/10/01 SUPPL 35 Approval Labeling
1955/06/22 SUPPL 34 Approval Efficacy
1955/05/26 SUPPL 33 Approval Labeling
1955/05/10 SUPPL 32 Approval Labeling
1955/04/01 SUPPL 31 Approval Labeling
1955/02/08 SUPPL 30 Approval Labeling
1955/02/02 SUPPL 29 Approval Efficacy
1954/11/16 SUPPL 26 Approval Manufacturing (CMC)
1954/11/16 SUPPL 25 Approval Manufacturing (CMC)
1954/11/08 SUPPL 28 Approval Labeling
1954/11/08 SUPPL 27 Approval Labeling
1954/10/21 SUPPL 24 Approval Efficacy
1954/04/02 SUPPL 22 Approval Manufacturing (CMC)
1954/01/06 SUPPL 21 Approval Labeling
1953/12/09 SUPPL 20 Approval Manufacturing (CMC)
1953/07/31 SUPPL 19 Approval Labeling
1953/05/26 SUPPL 18 Approval Labeling
1953/01/22 SUPPL 17 Approval Labeling
1952/12/05 SUPPL 16 Approval Labeling
1952/12/05 SUPPL 15 Approval Labeling
1952/06/27 ORIG 1 Approval UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:PENICILLIN G BENZATHINE 剂型/给药途径:INJECTABLE;INJECTION 规格:600,000 UNITS/ML 治疗等效代码:BC
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050141 001 NDA BICILLIN L-A PENICILLIN G BENZATHINE INJECTABLE;INJECTION 600,000 UNITS/ML Prescription Yes Yes BC Approved Prior to Jan 1, 1982 KING PHARMS LLC
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