药品注册申请号:050138
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 C-R PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE INJECTABLE;INJECTION 300,000 UNITS/ML;300,000 UNITS/ML Yes Yes None 1953/05/18 Approved Prior to Jan 1, 1982 Prescription
002 BICILLIN C-R PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE INJECTABLE;INJECTION 150,000 UNITS/ML;150,000 UNITS/ML Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 BICILLIN C-R 900/300 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE INJECTABLE;INJECTION 900,000 UNITS/2ML;300,000 UNITS/2ML Yes Yes None Approved Prior to Jan 1, 1982 Prescription
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
2019/08/26 SUPPL 241 Approval Labeling STANDARD
2019/04/30 SUPPL 240 Approval Labeling STANDARD
2018/11/05 SUPPL 239 Approval Labeling STANDARD
2017/12/07 SUPPL 238 Approval Labeling STANDARD
2015/10/13 SUPPL 236 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 235 Approval Labeling STANDARD
2012/09/06 SUPPL 234 Approval Labeling STANDARD
2009/12/18 SUPPL 231 Approval Labeling STANDARD
2005/11/17 SUPPL 229 Approval Labeling STANDARD
2004/12/22 SUPPL 228 Approval Labeling STANDARD
2002/04/29 SUPPL 223 Approval Labeling STANDARD
2002/04/29 SUPPL 222 Approval Labeling STANDARD
2002/03/01 SUPPL 219 Approval Labeling STANDARD
2001/03/23 SUPPL 221 Approval Manufacturing (CMC)
1997/11/25 SUPPL 220 Approval Manufacturing (CMC)
1993/09/22 SUPPL 217 Approval Labeling STANDARD
1993/09/09 SUPPL 13 Approval Manufacturing (CMC)
1989/05/31 SUPPL 215 Approval Labeling
1989/05/31 SUPPL 214 Approval Labeling
1989/05/31 SUPPL 213 Approval Labeling
1988/06/16 SUPPL 212 Approval Manufacturing (CMC)
1988/06/16 SUPPL 12 Approval Manufacturing (CMC)
1988/05/16 SUPPL 211 Approval Labeling
1988/04/14 SUPPL 210 Approval Manufacturing (CMC)
1987/11/17 SUPPL 209 Approval Labeling
1987/09/28 SUPPL 208 Approval Labeling
1986/12/08 SUPPL 206 Approval Manufacturing (CMC)
1986/12/05 SUPPL 205 Approval Labeling
1986/12/05 SUPPL 203 Approval Labeling
1985/11/18 SUPPL 202 Approval Manufacturing (CMC)
1983/10/12 SUPPL 201 Approval Labeling
1983/07/28 SUPPL 199 Approval Labeling
1983/07/19 SUPPL 200 Approval Labeling
1982/07/28 SUPPL 198 Approval Labeling
1982/07/16 SUPPL 197 Approval Labeling
1981/12/21 SUPPL 196 Approval Labeling
1981/12/14 SUPPL 195 Approval Labeling
1980/05/15 SUPPL 194 Approval Labeling
1979/07/27 SUPPL 193 Approval Labeling
1979/05/24 SUPPL 192 Approval Labeling
1978/04/24 SUPPL 191 Approval Manufacturing (CMC)
1977/10/14 SUPPL 190 Approval Labeling
1977/06/02 SUPPL 189 Approval Labeling
1977/01/11 SUPPL 188 Approval Labeling
1976/11/05 SUPPL 187 Approval Labeling
1976/11/03 SUPPL 186 Approval Labeling
1976/06/10 SUPPL 185 Approval Labeling
1976/06/07 SUPPL 184 Approval Labeling
1976/04/16 SUPPL 183 Approval Labeling
1976/03/23 SUPPL 182 Approval Labeling
1976/02/19 SUPPL 181 Approval Labeling
1976/02/10 SUPPL 180 Approval Labeling
1976/01/27 SUPPL 179 Approval Labeling
1975/12/25 SUPPL 174 Approval Labeling
1975/12/23 SUPPL 178 Approval Labeling
1975/11/21 SUPPL 177 Approval Labeling
1975/11/05 SUPPL 176 Approval Labeling
1975/09/10 SUPPL 175 Approval Labeling
1975/07/15 SUPPL 173 Approval Labeling
1975/03/21 SUPPL 172 Approval Labeling
1975/03/04 SUPPL 171 Approval Manufacturing (CMC)
1975/02/25 SUPPL 170 Approval Labeling
1974/12/19 SUPPL 169 Approval Labeling
1974/11/19 SUPPL 168 Approval Labeling
1974/10/22 SUPPL 167 Approval Labeling
1974/10/02 SUPPL 166 Approval Labeling
1974/10/02 SUPPL 165 Approval Labeling
1974/06/07 SUPPL 164 Approval Labeling
1974/05/29 SUPPL 163 Approval Labeling
1974/04/11 SUPPL 162 Approval Labeling
1974/03/28 SUPPL 161 Approval Labeling
1974/03/08 SUPPL 160 Approval Labeling
1973/12/07 SUPPL 159 Approval Labeling
1973/11/23 SUPPL 158 Approval Labeling
1973/11/13 SUPPL 157 Approval Labeling
1973/11/12 SUPPL 156 Approval Labeling
1973/09/14 SUPPL 155 Approval Labeling
1973/09/11 SUPPL 154 Approval Labeling
1973/08/01 SUPPL 153 Approval Labeling
1973/07/31 SUPPL 152 Approval Labeling
1973/06/21 SUPPL 151 Approval Labeling
1973/05/30 SUPPL 150 Approval Labeling
1973/05/18 SUPPL 149 Approval Labeling
1973/05/18 SUPPL 147 Approval Labeling
1973/05/15 SUPPL 148 Approval Labeling
1973/03/07 SUPPL 146 Approval Labeling
1973/02/26 SUPPL 145 Approval Labeling
1972/11/22 SUPPL 144 Approval Manufacturing (CMC)
1972/10/26 SUPPL 143 Approval Labeling
1972/09/05 SUPPL 142 Approval Labeling
1972/08/07 SUPPL 141 Approval Labeling
1972/07/25 SUPPL 140 Approval Labeling
1972/02/02 SUPPL 139 Approval Labeling
1971/05/18 SUPPL 138 Approval Labeling
1971/03/01 SUPPL 137 Approval Labeling
1971/01/27 SUPPL 136 Approval Labeling
1971/01/19 SUPPL 135 Approval Labeling
1971/01/19 SUPPL 134 Approval Labeling
1970/12/11 SUPPL 133 Approval Labeling
1970/12/11 SUPPL 130 Approval Labeling
1970/11/24 SUPPL 132 Approval Manufacturing (CMC)
1970/11/24 SUPPL 131 Approval Manufacturing (CMC)
1970/05/27 SUPPL 129 Approval Labeling
1970/04/27 SUPPL 128 Approval Labeling
1970/04/14 SUPPL 127 Approval Manufacturing (CMC)
1970/04/02 SUPPL 126 Approval Labeling
1970/03/27 SUPPL 125 Approval Labeling
1970/01/08 SUPPL 124 Approval Manufacturing (CMC)
1969/12/30 SUPPL 123 Approval Labeling
1969/12/18 SUPPL 122 Approval Labeling
1969/12/11 SUPPL 121 Approval Labeling
1969/12/04 SUPPL 120 Approval Labeling
1969/11/24 SUPPL 119 Approval Labeling
1969/11/04 SUPPL 118 Approval Labeling
1969/11/04 SUPPL 116 Approval Manufacturing (CMC)
1969/10/27 SUPPL 117 Approval Labeling
1969/09/04 SUPPL 113 Approval Manufacturing (CMC)
1969/08/04 SUPPL 115 Approval Labeling
1969/07/17 SUPPL 114 Approval Labeling
1969/01/30 SUPPL 112 Approval Manufacturing (CMC)
1968/12/12 SUPPL 111 Approval Labeling
1968/12/02 SUPPL 110 Approval Labeling
1968/11/19 SUPPL 109 Approval Labeling
1968/11/05 SUPPL 108 Approval Labeling
1968/10/29 SUPPL 107 Approval Labeling
1968/09/03 SUPPL 106 Approval Labeling
1968/08/23 SUPPL 105 Approval Labeling
1968/08/22 SUPPL 104 Approval Labeling
1968/08/02 SUPPL 103 Approval Labeling
1968/08/02 SUPPL 102 Approval Labeling
1968/06/17 SUPPL 101 Approval Labeling
1968/03/22 SUPPL 100 Approval Labeling
1968/01/04 SUPPL 99 Approval Labeling
1967/10/10 SUPPL 98 Approval Labeling
1967/09/08 SUPPL 97 Approval Labeling
1967/08/29 SUPPL 96 Approval Labeling
1967/08/23 SUPPL 95 Approval Labeling
1967/07/18 SUPPL 94 Approval Labeling
1967/06/30 SUPPL 93 Approval Labeling
1967/04/25 SUPPL 92 Approval Labeling
1967/04/24 SUPPL 91 Approval Labeling
1967/04/20 SUPPL 90 Approval Labeling
1967/04/19 SUPPL 88 Approval Labeling
1967/04/14 SUPPL 89 Approval Manufacturing (CMC)
1967/04/14 SUPPL 86 Approval Manufacturing (CMC)
1967/04/04 SUPPL 87 Approval Labeling
1967/03/29 SUPPL 85 Approval Labeling
1967/03/27 SUPPL 84 Approval Labeling
1967/03/17 SUPPL 83 Approval Labeling
1967/03/07 SUPPL 82 Approval Labeling
1966/12/08 SUPPL 81 Approval Manufacturing (CMC)
1966/11/03 SUPPL 80 Approval Labeling
1966/09/28 SUPPL 79 Approval Labeling
1966/09/02 SUPPL 78 Approval Labeling
1966/08/26 SUPPL 76 Approval Labeling
1966/08/25 SUPPL 77 Approval Labeling
1966/07/19 SUPPL 75 Approval Labeling
1966/06/10 SUPPL 74 Approval Labeling
1966/04/22 SUPPL 73 Approval Labeling
1966/04/08 SUPPL 72 Approval Labeling
1966/04/06 SUPPL 71 Approval Labeling
1966/03/18 SUPPL 70 Approval Labeling
1966/03/11 SUPPL 69 Approval Labeling
1966/02/14 SUPPL 68 Approval Labeling
1966/02/08 SUPPL 66 Approval Labeling
1966/02/04 SUPPL 67 Approval Manufacturing (CMC)
1966/01/06 SUPPL 65 Approval Labeling
1965/09/10 SUPPL 64 Approval Labeling
1965/08/12 SUPPL 63 Approval Labeling
1965/06/25 SUPPL 62 Approval Labeling
1965/05/07 SUPPL 61 Approval Labeling
1965/03/31 SUPPL 60 Approval Manufacturing (CMC)
1965/02/01 SUPPL 55 Approval Manufacturing (CMC)
1965/01/22 SUPPL 59 Approval Labeling
1965/01/07 SUPPL 58 Approval Labeling
1964/11/19 SUPPL 57 Approval Manufacturing (CMC)
1964/11/17 SUPPL 56 Approval Manufacturing (CMC)
1964/10/21 SUPPL 54 Approval Labeling
1964/06/03 SUPPL 53 Approval Labeling
1963/12/23 SUPPL 52 Approval Labeling
1963/12/10 SUPPL 46 Approval Labeling
1963/11/15 SUPPL 51 Approval Labeling
1963/10/07 SUPPL 47 Approval Labeling
1963/09/25 SUPPL 48 Approval Labeling
1963/09/18 SUPPL 50 Approval Labeling
1963/09/18 SUPPL 49 Approval Labeling
1963/07/31 SUPPL 45 Approval Labeling
1963/07/11 SUPPL 44 Approval Labeling
1963/05/28 SUPPL 43 Approval Labeling
1963/01/29 SUPPL 42 Approval Labeling
1963/01/04 SUPPL 41 Approval Labeling
1963/01/04 SUPPL 22 Approval Labeling
1962/12/19 SUPPL 39 Approval Labeling
1962/11/28 SUPPL 40 Approval Labeling
1962/10/11 SUPPL 38 Approval Labeling
1962/09/20 SUPPL 21 Approval Labeling
1962/09/20 SUPPL 19 Approval Labeling
1962/08/01 SUPPL 37 Approval Labeling
1962/03/23 SUPPL 36 Approval Labeling
1962/03/16 SUPPL 35 Approval Labeling
1962/03/09 SUPPL 34 Approval Labeling
1961/09/25 SUPPL 32 Approval Manufacturing (CMC)
1961/08/04 SUPPL 31 Approval Labeling
1961/08/04 SUPPL 30 Approval Labeling
1961/06/07 SUPPL 29 Approval Labeling
1961/04/05 SUPPL 27 Approval Labeling
1961/03/31 SUPPL 26 Approval Labeling
1961/03/21 SUPPL 25 Approval Labeling
1961/03/20 SUPPL 24 Approval Labeling
1961/03/20 SUPPL 23 Approval Labeling
1960/10/26 SUPPL 20 Approval Labeling
1956/11/20 SUPPL 18 Approval Labeling
1956/10/05 SUPPL 17 Approval Labeling
1956/09/24 SUPPL 16 Approval Labeling
1955/12/06 SUPPL 15 Approval Labeling
1955/07/15 SUPPL 14 Approval Manufacturing (CMC)
1955/05/26 SUPPL 11 Approval Labeling
1955/05/04 SUPPL 10 Approval Labeling
1954/12/06 SUPPL 9 Approval Labeling
1954/09/13 SUPPL 8 Approval Manufacturing (CMC)
1954/04/05 SUPPL 7 Approval Manufacturing (CMC)
1954/03/09 SUPPL 6 Approval Labeling
1953/11/19 SUPPL 5 Approval Labeling
1953/11/19 SUPPL 4 Approval Labeling
1953/09/09 SUPPL 3 Approval Labeling
1953/09/08 SUPPL 2 Approval Labeling
1953/05/18 ORIG 1 Approval UNKNOWN
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关联产品号独占权代码失效日期备注
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本品无治疗等效药品
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