اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BICILLIN L-A از شرکت KING PHARMS LLC
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf |
|
| 04/29/2002 | SUPPL-218 | Labeling |
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 |
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.
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