Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050141
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BICILLIN L-A PENICILLIN G BENZATHINE 600,000 UNITS/ML INJECTABLE;INJECTION Prescription BC Yes Yes
BICILLIN L-A PENICILLIN G BENZATHINE 300,000 UNITS/ML INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/1952 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
01/25/2021 SUPPL-240 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050141Orig1s240lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050141Orig1s240ltr.pdf
12/08/2020 SUPPL-239 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050141s239lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050138Orig1s243, 050141Orig1s239ltr.pdf
12/10/2020 SUPPL-238 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050141s238lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050138Orig1s242,050141Orig1s238ltr.pdf
04/30/2019 SUPPL-237 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050141s237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050138Orig1s240; 050141Orig1s237ltr.pdf
11/07/2018 SUPPL-236 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050141s236lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050141Orig1s236ltr.pdf
12/07/2017 SUPPL-235 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-233 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/2015/050141s233lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050141Orig1s233ltr.pdf
04/25/2014 SUPPL-232 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-231 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050141s231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050138Orig1s234,050141s231ltr.pdf
12/18/2009 SUPPL-226 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050141s226lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050138s231,050141s226ltr.pdf
11/17/2005 SUPPL-224 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050138s229,050141s224ltr.pdf
04/29/2002 SUPPL-219 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-218 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-217 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1998 SUPPL-216 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2002 SUPPL-215 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50141s215ltr.pdf
09/22/1993 SUPPL-213 Labeling

Label is not available on this site.

08/31/1993 SUPPL-212 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1982 SUPPL-211 Labeling

Label is not available on this site.

09/16/1982 SUPPL-210 Efficacy-New Dosing Regimen

Label is not available on this site.

07/28/1982 SUPPL-209 Labeling

Label is not available on this site.

12/21/1981 SUPPL-206 Labeling

Label is not available on this site.

05/15/1980 SUPPL-204 Labeling

Label is not available on this site.

07/27/1978 SUPPL-203 Labeling

Label is not available on this site.

11/03/1976 SUPPL-202 Labeling

Label is not available on this site.

06/10/1976 SUPPL-201 Labeling

Label is not available on this site.

06/07/1976 SUPPL-200 Labeling

Label is not available on this site.

02/10/1976 SUPPL-199 Labeling

Label is not available on this site.

02/10/1976 SUPPL-198 Labeling

Label is not available on this site.

02/10/1976 SUPPL-197 Labeling

Label is not available on this site.

01/27/1976 SUPPL-196 Labeling

Label is not available on this site.

11/05/1975 SUPPL-195 Labeling

Label is not available on this site.

10/03/1975 SUPPL-194 Labeling

Label is not available on this site.

07/15/1975 SUPPL-193 Labeling

Label is not available on this site.

03/04/1975 SUPPL-192 Labeling

Label is not available on this site.

01/09/1975 SUPPL-191 Labeling

Label is not available on this site.

11/19/1974 SUPPL-190 Labeling

Label is not available on this site.

11/19/1974 SUPPL-189 Labeling

Label is not available on this site.

11/19/1974 SUPPL-188 Labeling

Label is not available on this site.

11/19/1974 SUPPL-187 Labeling

Label is not available on this site.

10/25/1974 SUPPL-186 Labeling

Label is not available on this site.

06/20/1974 SUPPL-185 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/13/1974 SUPPL-184 Labeling

Label is not available on this site.

04/11/1974 SUPPL-183 Labeling

Label is not available on this site.

04/11/1974 SUPPL-182 Labeling

Label is not available on this site.

11/24/1974 SUPPL-181 Labeling

Label is not available on this site.

11/27/1973 SUPPL-180 Labeling

Label is not available on this site.

11/12/1973 SUPPL-179 Labeling

Label is not available on this site.

10/05/1973 SUPPL-178 Labeling

Label is not available on this site.

09/11/1973 SUPPL-177 Labeling

Label is not available on this site.

09/11/1973 SUPPL-176 Labeling

Label is not available on this site.

09/11/1973 SUPPL-175 Labeling

Label is not available on this site.

09/18/1972 SUPPL-174 Labeling

Label is not available on this site.

07/25/1972 SUPPL-173 Labeling

Label is not available on this site.

06/16/1972 SUPPL-172 Labeling

Label is not available on this site.

04/20/1972 SUPPL-171 Labeling

Label is not available on this site.

11/10/1971 SUPPL-170 Labeling

Label is not available on this site.

06/10/1971 SUPPL-169 Labeling

Label is not available on this site.

05/18/1971 SUPPL-168 Labeling

Label is not available on this site.

01/19/1971 SUPPL-167 Labeling

Label is not available on this site.

11/24/1970 SUPPL-166 Labeling

Label is not available on this site.

10/24/1970 SUPPL-165 Labeling

Label is not available on this site.

10/19/1970 SUPPL-164 Labeling

Label is not available on this site.

10/14/1970 SUPPL-163 Labeling

Label is not available on this site.

09/21/1970 SUPPL-162 Labeling

Label is not available on this site.

05/27/1970 SUPPL-161 Labeling

Label is not available on this site.

05/25/1970 SUPPL-160 Labeling

Label is not available on this site.

04/27/1970 SUPPL-159 Labeling

Label is not available on this site.

04/24/1970 SUPPL-158 Labeling

Label is not available on this site.

04/10/1970 SUPPL-157 Labeling

Label is not available on this site.

03/27/1970 SUPPL-156 Labeling

Label is not available on this site.

02/16/1970 SUPPL-155 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/04/1970 SUPPL-154 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/27/1970 SUPPL-153 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/15/1970 SUPPL-152 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/08/1970 SUPPL-151 Labeling

Label is not available on this site.

01/08/1970 SUPPL-150 Labeling

Label is not available on this site.

12/31/1969 SUPPL-149 Labeling

Label is not available on this site.

12/03/1969 SUPPL-148 Labeling

Label is not available on this site.

10/23/1969 SUPPL-147 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/11/1969 SUPPL-146 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/05/1969 SUPPL-145 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/24/1969 SUPPL-144 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/24/1969 SUPPL-143 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/09/1969 SUPPL-142 Labeling

Label is not available on this site.

04/10/1969 SUPPL-141 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/19/1969 SUPPL-140 Labeling

Label is not available on this site.

01/30/1969 SUPPL-138 Labeling

Label is not available on this site.

12/26/1968 SUPPL-137 Labeling

Label is not available on this site.

01/03/1969 SUPPL-136 Labeling

Label is not available on this site.

01/03/1969 SUPPL-135 Labeling

Label is not available on this site.

12/26/1968 SUPPL-134 Labeling

Label is not available on this site.

11/26/1968 SUPPL-133 Labeling

Label is not available on this site.

11/05/1968 SUPPL-132 Labeling

Label is not available on this site.

11/08/1968 SUPPL-131 Labeling

Label is not available on this site.

10/31/1968 SUPPL-130 Labeling

Label is not available on this site.

10/09/1968 SUPPL-129 Labeling

Label is not available on this site.

09/25/1968 SUPPL-128 Labeling

Label is not available on this site.

09/25/1968 SUPPL-127 Labeling

Label is not available on this site.

08/26/1968 SUPPL-126 Labeling

Label is not available on this site.

06/05/1968 SUPPL-125 Labeling

Label is not available on this site.

02/29/1968 SUPPL-124 Labeling

Label is not available on this site.

02/06/1968 SUPPL-123 Labeling

Label is not available on this site.

11/22/1967 SUPPL-122 Labeling

Label is not available on this site.

08/11/1967 SUPPL-120 Labeling

Label is not available on this site.

06/01/1967 SUPPL-119 Labeling

Label is not available on this site.

05/23/1967 SUPPL-118 Labeling

Label is not available on this site.

05/05/1967 SUPPL-117 Labeling

Label is not available on this site.

05/01/1967 SUPPL-116 Labeling

Label is not available on this site.

04/19/1967 SUPPL-115 Labeling

Label is not available on this site.

04/17/1967 SUPPL-114 Labeling

Label is not available on this site.

04/14/1967 SUPPL-113 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/06/1967 SUPPL-112 Labeling

Label is not available on this site.

03/29/1967 SUPPL-111 Labeling

Label is not available on this site.

03/17/1967 SUPPL-110 Labeling

Label is not available on this site.

02/24/1967 SUPPL-109 Labeling

Label is not available on this site.

01/20/1967 SUPPL-108 Labeling

Label is not available on this site.

07/06/1966 SUPPL-107 Labeling

Label is not available on this site.

06/27/1966 SUPPL-106 Labeling

Label is not available on this site.

05/16/1966 SUPPL-105 Labeling

Label is not available on this site.

05/10/1966 SUPPL-104 Labeling

Label is not available on this site.

03/15/1966 SUPPL-103 Labeling

Label is not available on this site.

03/07/1966 SUPPL-102 Labeling

Label is not available on this site.

03/02/1966 SUPPL-101 Labeling

Label is not available on this site.

02/15/1966 SUPPL-100 Labeling

Label is not available on this site.

02/08/1966 SUPPL-99 Labeling

Label is not available on this site.

12/13/1965 SUPPL-98 Labeling

Label is not available on this site.

11/03/1965 SUPPL-97 Labeling

Label is not available on this site.

11/02/1965 SUPPL-96 Labeling

Label is not available on this site.

10/28/1965 SUPPL-95 Labeling

Label is not available on this site.

09/15/1965 SUPPL-94 Labeling

Label is not available on this site.

05/06/1965 SUPPL-93 Labeling

Label is not available on this site.

03/31/1965 SUPPL-92 Labeling

Label is not available on this site.

03/31/1965 SUPPL-91 Labeling

Label is not available on this site.

03/09/1965 SUPPL-90 Labeling

Label is not available on this site.

01/22/1965 SUPPL-89 Labeling

Label is not available on this site.

11/17/1964 SUPPL-88 Labeling

Label is not available on this site.

10/15/1964 SUPPL-87 Labeling

Label is not available on this site.

10/07/1964 SUPPL-86 Labeling

Label is not available on this site.

08/13/1964 SUPPL-85 Labeling

Label is not available on this site.

07/13/1964 SUPPL-84 Labeling

Label is not available on this site.

04/29/1964 SUPPL-83 Labeling

Label is not available on this site.

02/10/1964 SUPPL-82 Labeling

Label is not available on this site.

12/26/1963 SUPPL-81 Labeling

Label is not available on this site.

11/22/1963 SUPPL-80 Labeling

Label is not available on this site.

12/09/1963 SUPPL-79 Labeling

Label is not available on this site.

10/16/1963 SUPPL-78 Labeling

Label is not available on this site.

10/16/1963 SUPPL-77 Labeling

Label is not available on this site.

10/18/1963 SUPPL-76 Labeling

Label is not available on this site.

09/25/1963 SUPPL-75 Labeling

Label is not available on this site.

09/18/1963 SUPPL-74 Labeling

Label is not available on this site.

09/24/1963 SUPPL-73 Labeling

Label is not available on this site.

09/03/1963 SUPPL-72 Labeling

Label is not available on this site.

09/06/1963 SUPPL-71 Labeling

Label is not available on this site.

09/06/1963 SUPPL-70 Labeling

Label is not available on this site.

07/31/1963 SUPPL-69 Labeling

Label is not available on this site.

07/11/1963 SUPPL-68 Labeling

Label is not available on this site.

07/11/1963 SUPPL-67 Labeling

Label is not available on this site.

07/10/1963 SUPPL-66 Labeling

Label is not available on this site.

05/28/1963 SUPPL-65 Labeling

Label is not available on this site.

04/05/1963 SUPPL-64 Labeling

Label is not available on this site.

04/05/1963 SUPPL-63 Labeling

Label is not available on this site.

12/19/1962 SUPPL-62 Labeling

Label is not available on this site.

12/19/1962 SUPPL-61 Labeling

Label is not available on this site.

10/12/1962 SUPPL-59 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/23/1963 SUPPL-58 Labeling

Label is not available on this site.

03/23/1963 SUPPL-57 Labeling

Label is not available on this site.

01/15/1962 SUPPL-56 Labeling

Label is not available on this site.

08/04/1961 SUPPL-54 Labeling

Label is not available on this site.

08/04/1961 SUPPL-53 Labeling

Label is not available on this site.

07/10/1961 SUPPL-52 Labeling

Label is not available on this site.

06/16/1961 SUPPL-51 Labeling

Label is not available on this site.

06/16/1961 SUPPL-50 Labeling

Label is not available on this site.

04/05/1961 SUPPL-49 Labeling

Label is not available on this site.

04/05/1961 SUPPL-48 Labeling

Label is not available on this site.

03/31/1961 SUPPL-47 Labeling

Label is not available on this site.

03/24/1961 SUPPL-46 Labeling

Label is not available on this site.

05/02/1961 SUPPL-45 Labeling

Label is not available on this site.

03/21/1961 SUPPL-44 Labeling

Label is not available on this site.

03/20/1961 SUPPL-43 Labeling

Label is not available on this site.

03/30/1961 SUPPL-42 Labeling

Label is not available on this site.

12/22/1960 SUPPL-41 Labeling

Label is not available on this site.

10/03/1960 SUPPL-40 Labeling

Label is not available on this site.

12/22/1960 SUPPL-39 Labeling

Label is not available on this site.

06/16/1988 SUPPL-38 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/01/1956 SUPPL-35 Labeling

Label is not available on this site.

06/22/1955 SUPPL-34 Efficacy-New Indication

Label is not available on this site.

05/26/1955 SUPPL-33 Labeling

Label is not available on this site.

05/10/1955 SUPPL-32 Labeling

Label is not available on this site.

04/01/1955 SUPPL-31 Labeling

Label is not available on this site.

02/08/1955 SUPPL-30 Labeling

Label is not available on this site.

02/02/1955 SUPPL-29 Efficacy-New Indication

Label is not available on this site.

11/08/1954 SUPPL-28 Labeling

Label is not available on this site.

11/08/1954 SUPPL-27 Labeling

Label is not available on this site.

11/16/1954 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/16/1954 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/21/1954 SUPPL-24 Efficacy-New Indication

Label is not available on this site.

04/02/1954 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/06/1954 SUPPL-21 Labeling

Label is not available on this site.

12/09/1953 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/31/1953 SUPPL-19 Labeling

Label is not available on this site.

05/26/1953 SUPPL-18 Labeling

Label is not available on this site.

01/22/1953 SUPPL-17 Labeling

Label is not available on this site.

12/05/1952 SUPPL-16 Labeling

Label is not available on this site.

12/05/1952 SUPPL-15 Labeling

Label is not available on this site.

06/16/1988 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/31/1989 SUPPL-13 Labeling

Label is not available on this site.

06/16/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/16/1988 SUPPL-10 Labeling

Label is not available on this site.

05/03/1988 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/28/1987 SUPPL-8 Labeling

Label is not available on this site.

11/17/1987 SUPPL-7 Labeling

Label is not available on this site.

12/08/1986 SUPPL-6 Labeling

Label is not available on this site.

12/05/1986 SUPPL-5 Labeling

Label is not available on this site.

11/18/1985 SUPPL-4 Labeling

Label is not available on this site.

07/29/1985 SUPPL-3 Labeling

Label is not available on this site.

07/08/1983 SUPPL-2 Labeling

Label is not available on this site.

05/27/1983 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2021 SUPPL-240 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050141Orig1s240lbl.pdf
12/10/2020 SUPPL-238 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050141s238lbl.pdf
12/08/2020 SUPPL-239 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050141s239lbl.pdf
04/30/2019 SUPPL-237 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050141s237lbl.pdf
11/07/2018 SUPPL-236 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050141s236lbl.pdf
10/13/2015 SUPPL-233 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/2015/050141s233lbl.pdf
04/25/2014 SUPPL-232 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf
09/06/2012 SUPPL-231 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050141s231lbl.pdf
12/18/2009 SUPPL-226 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050141s226lbl.pdf

BICILLIN L-A

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English