Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LINCOCIN | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1964 | 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 |
|---|---|---|---|---|---|
| 04/11/2022 | SUPPL-187 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050317Orig1s187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050317Orig1s187ltr.pdf | |
| 04/01/2018 | SUPPL-184 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050317s184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050317s184ltr.pdf | |
| 11/16/2018 | SUPPL-183 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050317s183lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050317Orig1s183ltr.pdf | |
| 11/08/2016 | SUPPL-180 | 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/2016/050317s179s180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050317Orig1s179,050317Orig1s180ltr.pdf |
| 11/08/2016 | SUPPL-179 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050317s179s180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050317Orig1s179,050317Orig1s180ltr.pdf | |
| 10/15/2014 | SUPPL-177 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050317s177lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050317Orig1s177ltr.pdf | |
| 02/27/2008 | SUPPL-172 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050317s172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050317s172ltr.pdf | |
| 06/02/2004 | SUPPL-167 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50317slr167,50316slr099ltr.pdf |
| 10/17/2002 | SUPPL-164 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-163 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-162 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1987 | SUPPL-161 | Labeling |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-158 | Labeling |
Label is not available on this site. |
||
| 08/03/1982 | SUPPL-157 | Labeling |
Label is not available on this site. |
||
| 09/17/1981 | SUPPL-155 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/1980 | SUPPL-154 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/09/1980 | SUPPL-153 | Labeling |
Label is not available on this site. |
||
| 09/09/1980 | SUPPL-152 | Labeling |
Label is not available on this site. |
||
| 07/30/1980 | SUPPL-151 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/1980 | SUPPL-150 | Labeling |
Label is not available on this site. |
||
| 08/24/1979 | SUPPL-149 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/20/1979 | SUPPL-148 | Labeling |
Label is not available on this site. |
||
| 03/22/1979 | SUPPL-147 | Labeling |
Label is not available on this site. |
||
| 02/27/1979 | SUPPL-146 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1979 | SUPPL-145 | Labeling |
Label is not available on this site. |
||
| 07/10/1978 | SUPPL-144 | Labeling |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-143 | Labeling |
Label is not available on this site. |
||
| 06/24/1977 | SUPPL-142 | Labeling |
Label is not available on this site. |
||
| 03/29/1977 | SUPPL-141 | Labeling |
Label is not available on this site. |
||
| 02/27/1978 | SUPPL-140 | Labeling |
Label is not available on this site. |
||
| 12/07/1976 | SUPPL-139 | Labeling |
Label is not available on this site. |
||
| 08/10/1976 | SUPPL-138 | Labeling |
Label is not available on this site. |
||
| 07/26/1976 | SUPPL-137 | Labeling |
Label is not available on this site. |
||
| 12/29/1975 | SUPPL-136 | Labeling |
Label is not available on this site. |
||
| 12/02/1975 | SUPPL-135 | Labeling |
Label is not available on this site. |
||
| 10/09/1975 | SUPPL-134 | Labeling |
Label is not available on this site. |
||
| 07/03/1975 | SUPPL-133 | Labeling |
Label is not available on this site. |
||
| 05/30/1975 | SUPPL-132 | Labeling |
Label is not available on this site. |
||
| 11/19/1974 | SUPPL-130 | Labeling |
Label is not available on this site. |
||
| 11/19/1974 | SUPPL-129 | Labeling |
Label is not available on this site. |
||
| 08/26/1974 | SUPPL-128 | Labeling |
Label is not available on this site. |
||
| 08/09/1974 | SUPPL-127 | Labeling |
Label is not available on this site. |
||
| 08/09/1974 | SUPPL-126 | Labeling |
Label is not available on this site. |
||
| 06/17/1974 | SUPPL-125 | Labeling |
Label is not available on this site. |
||
| 06/06/1974 | SUPPL-124 | Labeling |
Label is not available on this site. |
||
| 04/24/1974 | SUPPL-123 | Labeling |
Label is not available on this site. |
||
| 04/09/1974 | SUPPL-122 | Labeling |
Label is not available on this site. |
||
| 01/29/1974 | SUPPL-121 | Labeling |
Label is not available on this site. |
||
| 12/11/1973 | SUPPL-120 | Labeling |
Label is not available on this site. |
||
| 12/07/1973 | SUPPL-119 | Labeling |
Label is not available on this site. |
||
| 07/13/1973 | SUPPL-118 | Labeling |
Label is not available on this site. |
||
| 05/07/1973 | SUPPL-117 | Labeling |
Label is not available on this site. |
||
| 03/06/1973 | SUPPL-116 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/02/1973 | SUPPL-115 | Labeling |
Label is not available on this site. |
||
| 01/30/1973 | SUPPL-114 | Labeling |
Label is not available on this site. |
||
| 11/24/1972 | SUPPL-113 | Labeling |
Label is not available on this site. |
||
| 11/17/1972 | SUPPL-112 | Labeling |
Label is not available on this site. |
||
| 10/11/1972 | SUPPL-111 | Labeling |
Label is not available on this site. |
||
| 10/06/1972 | SUPPL-110 | Labeling |
Label is not available on this site. |
||
| 10/02/1972 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
| 08/22/1972 | SUPPL-108 | Labeling |
Label is not available on this site. |
||
| 08/11/1972 | SUPPL-107 | Labeling |
Label is not available on this site. |
||
| 08/03/1972 | SUPPL-106 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1972 | SUPPL-105 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1972 | SUPPL-104 | Labeling |
Label is not available on this site. |
||
| 05/04/1972 | SUPPL-103 | Labeling |
Label is not available on this site. |
||
| 04/10/1972 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 03/06/1972 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
| 02/09/1972 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
| 01/31/1972 | SUPPL-99 | Labeling |
Label is not available on this site. |
||
| 01/25/1972 | SUPPL-98 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/16/1971 | SUPPL-97 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/06/1971 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 11/22/1971 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 11/03/1971 | SUPPL-94 | Labeling |
Label is not available on this site. |
||
| 10/14/1971 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
| 10/04/1971 | SUPPL-92 | Labeling |
Label is not available on this site. |
||
| 08/25/1971 | SUPPL-91 | Labeling |
Label is not available on this site. |
||
| 08/19/1971 | SUPPL-90 | Labeling |
Label is not available on this site. |
||
| 08/10/1971 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 08/05/1971 | SUPPL-88 | Labeling |
Label is not available on this site. |
||
| 06/29/1971 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 08/04/1971 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 06/01/1971 | SUPPL-85 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/29/1971 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 06/01/1971 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 02/19/1971 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 02/16/1971 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 01/19/1971 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 12/15/1970 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 12/10/1970 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 11/05/1970 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 10/29/1970 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 08/06/1970 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 07/08/1970 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 06/30/1970 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 04/21/1970 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 04/14/1970 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 04/02/1970 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 03/11/1970 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 06/27/1969 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 06/27/1969 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 06/03/1969 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 04/10/1969 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 03/04/1969 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 03/04/1969 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 03/04/1969 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 07/24/1968 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 06/11/1968 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1968 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 05/27/1968 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 04/24/1968 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 04/10/1968 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 04/03/1968 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1968 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 03/08/1968 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 03/12/1968 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1968 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 01/30/1968 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/23/1968 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/23/1968 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 01/22/1968 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 12/26/1967 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/14/1967 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 12/26/1967 | SUPPL-39 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/08/1967 | SUPPL-38 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/09/1967 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 07/26/1967 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 07/14/1967 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 06/30/1967 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 04/26/1967 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/26/1967 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 04/17/1967 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/14/1967 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 12/22/1966 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 12/26/1967 | SUPPL-27 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/31/1966 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/31/1966 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/14/1966 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/29/1965 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/10/1965 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/01/1965 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1965 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/16/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/06/1965 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/07/1965 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/14/1965 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/15/1993 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/28/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/22/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/21/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/03/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/23/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/15/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/28/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/20/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/10/1982 | 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 |
|---|---|---|---|---|---|
| 04/11/2022 | SUPPL-187 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050317Orig1s187lbl.pdf | |
| 04/11/2022 | SUPPL-187 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050317Orig1s187lbl.pdf | |
| 11/16/2018 | SUPPL-183 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050317s183lbl.pdf | |
| 04/01/2018 | SUPPL-184 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050317s184lbl.pdf | |
| 11/08/2016 | SUPPL-180 | 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/2016/050317s179s180lbl.pdf |
| 11/08/2016 | SUPPL-179 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050317s179s180lbl.pdf | |
| 10/15/2014 | SUPPL-177 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050317s177lbl.pdf | |
| 02/27/2008 | SUPPL-172 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050317s172lbl.pdf |
LINCOCIN
INJECTABLE;INJECTION; EQ 300MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LINCOCIN | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050317 | PFIZER |
| LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215657 | GLAND PHARMA LTD |
| LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215082 | MICRO LABS |
| LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201746 | XGEN PHARMS |