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 C-R از شرکت KING PHARMS LLC
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50138s228ltr.pdf |
|
| 04/29/2002 | SUPPL-223 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50138s222.pdf |
|
| 04/29/2002 | SUPPL-222 | Labeling |
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 |
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 |
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