U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050138
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BICILLIN C-R PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 300,000 UNITS/ML;300,000 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
BICILLIN C-R PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 150,000 UNITS/ML;150,000 UNITS/ML INJECTABLE;INJECTION Discontinued None Yes No
BICILLIN C-R 900/300 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 900,000 UNITS/2ML;300,000 UNITS/2ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/1953 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2020 SUPPL-243 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050138s243lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050138Orig1s243, 050141Orig1s239ltr.pdf
12/10/2020 SUPPL-242 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050138s242lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050138Orig1s242,050141Orig1s238ltr.pdf
08/26/2019 SUPPL-241 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050138s241lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050138Orig1s241ltr.pdf
04/30/2019 SUPPL-240 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050138s240,050141s237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050138Orig1s240; 050141Orig1s237ltr.pdf
11/05/2018 SUPPL-239 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050138s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050138Orig1s239ltr.pdf
12/07/2017 SUPPL-238 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050138Orig1s238, 050141Orig1s235ltr.pdf
10/13/2015 SUPPL-236 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050138s236lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050138Orig1s236ltr.pdf
04/25/2014 SUPPL-235 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050138Orig1s235,050141Orig1s232ltr.pdf
09/06/2012 SUPPL-234 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050138s234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050138Orig1s234,050141s231ltr.pdf
12/18/2009 SUPPL-231 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050138s231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050138s231,050141s226ltr.pdf
11/17/2005 SUPPL-229 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050138s229,050141s224ltr.pdf
12/22/2004 SUPPL-228 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50138s228ltr.pdf
04/29/2002 SUPPL-223 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf
04/29/2002 SUPPL-222 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf
03/23/2001 SUPPL-221 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1997 SUPPL-220 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2002 SUPPL-219 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s219ltr.pdf
09/22/1993 SUPPL-217 Labeling

Label is not available on this site.

05/31/1989 SUPPL-215 Labeling

Label is not available on this site.

05/31/1989 SUPPL-214 Labeling

Label is not available on this site.

05/31/1989 SUPPL-213 Labeling

Label is not available on this site.

06/16/1988 SUPPL-212 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1988 SUPPL-211 Labeling

Label is not available on this site.

04/14/1988 SUPPL-210 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1987 SUPPL-209 Labeling

Label is not available on this site.

09/28/1987 SUPPL-208 Labeling

Label is not available on this site.

12/08/1986 SUPPL-206 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/05/1986 SUPPL-205 Labeling

Label is not available on this site.

12/05/1986 SUPPL-203 Labeling

Label is not available on this site.

11/18/1985 SUPPL-202 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1983 SUPPL-201 Labeling

Label is not available on this site.

07/19/1983 SUPPL-200 Labeling

Label is not available on this site.

07/28/1983 SUPPL-199 Labeling

Label is not available on this site.

07/28/1982 SUPPL-198 Labeling

Label is not available on this site.

07/16/1982 SUPPL-197 Labeling

Label is not available on this site.

12/21/1981 SUPPL-196 Labeling

Label is not available on this site.

12/14/1981 SUPPL-195 Labeling

Label is not available on this site.

05/15/1980 SUPPL-194 Labeling

Label is not available on this site.

07/27/1979 SUPPL-193 Labeling

Label is not available on this site.

05/24/1979 SUPPL-192 Labeling

Label is not available on this site.

04/24/1978 SUPPL-191 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1977 SUPPL-190 Labeling

Label is not available on this site.

06/02/1977 SUPPL-189 Labeling

Label is not available on this site.

01/11/1977 SUPPL-188 Labeling

Label is not available on this site.

11/05/1976 SUPPL-187 Labeling

Label is not available on this site.

11/03/1976 SUPPL-186 Labeling

Label is not available on this site.

06/10/1976 SUPPL-185 Labeling

Label is not available on this site.

06/07/1976 SUPPL-184 Labeling

Label is not available on this site.

04/16/1976 SUPPL-183 Labeling

Label is not available on this site.

03/23/1976 SUPPL-182 Labeling

Label is not available on this site.

02/19/1976 SUPPL-181 Labeling

Label is not available on this site.

02/10/1976 SUPPL-180 Labeling

Label is not available on this site.

01/27/1976 SUPPL-179 Labeling

Label is not available on this site.

12/23/1975 SUPPL-178 Labeling

Label is not available on this site.

11/21/1975 SUPPL-177 Labeling

Label is not available on this site.

11/05/1975 SUPPL-176 Labeling

Label is not available on this site.

09/10/1975 SUPPL-175 Labeling

Label is not available on this site.

12/25/1975 SUPPL-174 Labeling

Label is not available on this site.

07/15/1975 SUPPL-173 Labeling

Label is not available on this site.

03/21/1975 SUPPL-172 Labeling

Label is not available on this site.

03/04/1975 SUPPL-171 Manufacturing (CMC)

Label is not available on this site.

02/25/1975 SUPPL-170 Labeling

Label is not available on this site.

12/19/1974 SUPPL-169 Labeling

Label is not available on this site.

11/19/1974 SUPPL-168 Labeling

Label is not available on this site.

10/22/1974 SUPPL-167 Labeling

Label is not available on this site.

10/02/1974 SUPPL-166 Labeling

Label is not available on this site.

10/02/1974 SUPPL-165 Labeling

Label is not available on this site.

06/07/1974 SUPPL-164 Labeling

Label is not available on this site.

05/29/1974 SUPPL-163 Labeling

Label is not available on this site.

04/11/1974 SUPPL-162 Labeling

Label is not available on this site.

03/28/1974 SUPPL-161 Labeling

Label is not available on this site.

03/08/1974 SUPPL-160 Labeling

Label is not available on this site.

12/07/1973 SUPPL-159 Labeling

Label is not available on this site.

11/23/1973 SUPPL-158 Labeling

Label is not available on this site.

11/13/1973 SUPPL-157 Labeling

Label is not available on this site.

11/12/1973 SUPPL-156 Labeling

Label is not available on this site.

09/14/1973 SUPPL-155 Labeling

Label is not available on this site.

09/11/1973 SUPPL-154 Labeling

Label is not available on this site.

08/01/1973 SUPPL-153 Labeling

Label is not available on this site.

07/31/1973 SUPPL-152 Labeling

Label is not available on this site.

06/21/1973 SUPPL-151 Labeling

Label is not available on this site.

05/30/1973 SUPPL-150 Labeling

Label is not available on this site.

05/18/1973 SUPPL-149 Labeling

Label is not available on this site.

05/15/1973 SUPPL-148 Labeling

Label is not available on this site.

05/18/1973 SUPPL-147 Labeling

Label is not available on this site.

03/07/1973 SUPPL-146 Labeling

Label is not available on this site.

02/26/1973 SUPPL-145 Labeling

Label is not available on this site.

11/22/1972 SUPPL-144 Manufacturing (CMC)

Label is not available on this site.

10/26/1972 SUPPL-143 Labeling

Label is not available on this site.

09/05/1972 SUPPL-142 Labeling

Label is not available on this site.

08/07/1972 SUPPL-141 Labeling

Label is not available on this site.

07/25/1972 SUPPL-140 Labeling

Label is not available on this site.

02/02/1972 SUPPL-139 Labeling

Label is not available on this site.

05/18/1971 SUPPL-138 Labeling

Label is not available on this site.

03/01/1971 SUPPL-137 Labeling

Label is not available on this site.

01/27/1971 SUPPL-136 Labeling

Label is not available on this site.

01/19/1971 SUPPL-135 Labeling

Label is not available on this site.

01/19/1971 SUPPL-134 Labeling

Label is not available on this site.

12/11/1970 SUPPL-133 Labeling

Label is not available on this site.

11/24/1970 SUPPL-132 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1970 SUPPL-131 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1970 SUPPL-130 Labeling

Label is not available on this site.

05/27/1970 SUPPL-129 Labeling

Label is not available on this site.

04/27/1970 SUPPL-128 Labeling

Label is not available on this site.

04/14/1970 SUPPL-127 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1970 SUPPL-126 Labeling

Label is not available on this site.

03/27/1970 SUPPL-125 Labeling

Label is not available on this site.

01/08/1970 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

12/30/1969 SUPPL-123 Labeling

Label is not available on this site.

12/18/1969 SUPPL-122 Labeling

Label is not available on this site.

12/11/1969 SUPPL-121 Labeling

Label is not available on this site.

12/04/1969 SUPPL-120 Labeling

Label is not available on this site.

11/24/1969 SUPPL-119 Labeling

Label is not available on this site.

11/04/1969 SUPPL-118 Labeling

Label is not available on this site.

10/27/1969 SUPPL-117 Labeling

Label is not available on this site.

11/04/1969 SUPPL-116 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/04/1969 SUPPL-115 Labeling

Label is not available on this site.

07/17/1969 SUPPL-114 Labeling

Label is not available on this site.

09/04/1969 SUPPL-113 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/30/1969 SUPPL-112 Manufacturing (CMC)

Label is not available on this site.

12/12/1968 SUPPL-111 Labeling

Label is not available on this site.

12/02/1968 SUPPL-110 Labeling

Label is not available on this site.

11/19/1968 SUPPL-109 Labeling

Label is not available on this site.

11/05/1968 SUPPL-108 Labeling

Label is not available on this site.

10/29/1968 SUPPL-107 Labeling

Label is not available on this site.

09/03/1968 SUPPL-106 Labeling

Label is not available on this site.

08/23/1968 SUPPL-105 Labeling

Label is not available on this site.

08/22/1968 SUPPL-104 Labeling

Label is not available on this site.

08/02/1968 SUPPL-103 Labeling

Label is not available on this site.

08/02/1968 SUPPL-102 Labeling

Label is not available on this site.

06/17/1968 SUPPL-101 Labeling

Label is not available on this site.

03/22/1968 SUPPL-100 Labeling

Label is not available on this site.

01/04/1968 SUPPL-99 Labeling

Label is not available on this site.

10/10/1967 SUPPL-98 Labeling

Label is not available on this site.

09/08/1967 SUPPL-97 Labeling

Label is not available on this site.

08/29/1967 SUPPL-96 Labeling

Label is not available on this site.

08/23/1967 SUPPL-95 Labeling

Label is not available on this site.

07/18/1967 SUPPL-94 Labeling

Label is not available on this site.

06/30/1967 SUPPL-93 Labeling

Label is not available on this site.

04/25/1967 SUPPL-92 Labeling

Label is not available on this site.

04/24/1967 SUPPL-91 Labeling

Label is not available on this site.

04/20/1967 SUPPL-90 Labeling

Label is not available on this site.

04/14/1967 SUPPL-89 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/19/1967 SUPPL-88 Labeling

Label is not available on this site.

04/04/1967 SUPPL-87 Labeling

Label is not available on this site.

04/14/1967 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

03/29/1967 SUPPL-85 Labeling

Label is not available on this site.

03/27/1967 SUPPL-84 Labeling

Label is not available on this site.

03/17/1967 SUPPL-83 Labeling

Label is not available on this site.

03/07/1967 SUPPL-82 Labeling

Label is not available on this site.

12/08/1966 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

11/03/1966 SUPPL-80 Labeling

Label is not available on this site.

09/28/1966 SUPPL-79 Labeling

Label is not available on this site.

09/02/1966 SUPPL-78 Labeling

Label is not available on this site.

08/25/1966 SUPPL-77 Labeling

Label is not available on this site.

08/26/1966 SUPPL-76 Labeling

Label is not available on this site.

07/19/1966 SUPPL-75 Labeling

Label is not available on this site.

06/10/1966 SUPPL-74 Labeling

Label is not available on this site.

04/22/1966 SUPPL-73 Labeling

Label is not available on this site.

04/08/1966 SUPPL-72 Labeling

Label is not available on this site.

04/06/1966 SUPPL-71 Labeling

Label is not available on this site.

03/18/1966 SUPPL-70 Labeling

Label is not available on this site.

03/11/1966 SUPPL-69 Labeling

Label is not available on this site.

02/14/1966 SUPPL-68 Labeling

Label is not available on this site.

02/04/1966 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

02/08/1966 SUPPL-66 Labeling

Label is not available on this site.

01/06/1966 SUPPL-65 Labeling

Label is not available on this site.

09/10/1965 SUPPL-64 Labeling

Label is not available on this site.

08/12/1965 SUPPL-63 Labeling

Label is not available on this site.

06/25/1965 SUPPL-62 Labeling

Label is not available on this site.

05/07/1965 SUPPL-61 Labeling

Label is not available on this site.

03/31/1965 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

01/22/1965 SUPPL-59 Labeling

Label is not available on this site.

01/07/1965 SUPPL-58 Labeling

Label is not available on this site.

11/19/1964 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

11/17/1964 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

02/01/1965 SUPPL-55 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/21/1964 SUPPL-54 Labeling

Label is not available on this site.

06/03/1964 SUPPL-53 Labeling

Label is not available on this site.

12/23/1963 SUPPL-52 Labeling

Label is not available on this site.

11/15/1963 SUPPL-51 Labeling

Label is not available on this site.

09/18/1963 SUPPL-50 Labeling

Label is not available on this site.

09/18/1963 SUPPL-49 Labeling

Label is not available on this site.

09/25/1963 SUPPL-48 Labeling

Label is not available on this site.

10/07/1963 SUPPL-47 Labeling

Label is not available on this site.

12/10/1963 SUPPL-46 Labeling

Label is not available on this site.

07/31/1963 SUPPL-45 Labeling

Label is not available on this site.

07/11/1963 SUPPL-44 Labeling

Label is not available on this site.

05/28/1963 SUPPL-43 Labeling

Label is not available on this site.

01/29/1963 SUPPL-42 Labeling

Label is not available on this site.

01/04/1963 SUPPL-41 Labeling

Label is not available on this site.

11/28/1962 SUPPL-40 Labeling

Label is not available on this site.

12/19/1962 SUPPL-39 Labeling

Label is not available on this site.

10/11/1962 SUPPL-38 Labeling

Label is not available on this site.

08/01/1962 SUPPL-37 Labeling

Label is not available on this site.

03/23/1962 SUPPL-36 Labeling

Label is not available on this site.

03/16/1962 SUPPL-35 Labeling

Label is not available on this site.

03/09/1962 SUPPL-34 Labeling

Label is not available on this site.

09/25/1961 SUPPL-32 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/04/1961 SUPPL-31 Labeling

Label is not available on this site.

08/04/1961 SUPPL-30 Labeling

Label is not available on this site.

06/07/1961 SUPPL-29 Labeling

Label is not available on this site.

04/05/1961 SUPPL-27 Labeling

Label is not available on this site.

03/31/1961 SUPPL-26 Labeling

Label is not available on this site.

03/21/1961 SUPPL-25 Labeling

Label is not available on this site.

03/20/1961 SUPPL-24 Labeling

Label is not available on this site.

03/20/1961 SUPPL-23 Labeling

Label is not available on this site.

01/04/1963 SUPPL-22 Labeling

Label is not available on this site.

09/20/1962 SUPPL-21 Labeling

Label is not available on this site.

10/26/1960 SUPPL-20 Labeling

Label is not available on this site.

09/20/1962 SUPPL-19 Labeling

Label is not available on this site.

11/20/1956 SUPPL-18 Labeling

Label is not available on this site.

10/05/1956 SUPPL-17 Labeling

Label is not available on this site.

09/24/1956 SUPPL-16 Labeling

Label is not available on this site.

12/06/1955 SUPPL-15 Labeling

Label is not available on this site.

07/15/1955 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/09/1993 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/16/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/26/1955 SUPPL-11 Labeling

Label is not available on this site.

05/04/1955 SUPPL-10 Labeling

Label is not available on this site.

12/06/1954 SUPPL-9 Labeling

Label is not available on this site.

09/13/1954 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/05/1954 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/09/1954 SUPPL-6 Labeling

Label is not available on this site.

11/19/1953 SUPPL-5 Labeling

Label is not available on this site.

11/19/1953 SUPPL-4 Labeling

Label is not available on this site.

09/09/1953 SUPPL-3 Labeling

Label is not available on this site.

09/08/1953 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/10/2020 SUPPL-242 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050138s242lbl.pdf
12/08/2020 SUPPL-243 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050138s243lbl.pdf
08/26/2019 SUPPL-241 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050138s241lbl.pdf
04/30/2019 SUPPL-240 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050138s240,050141s237lbl.pdf
11/05/2018 SUPPL-239 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050138s039lbl.pdf
10/13/2015 SUPPL-236 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050138s236lbl.pdf
04/25/2014 SUPPL-235 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf
09/06/2012 SUPPL-234 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050138s234lbl.pdf
12/18/2009 SUPPL-231 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050138s231lbl.pdf
Back to Top