Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050317
Company: PHARMACIA AND UPJOHN
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
11/08/2016 SUPPL-180 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
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
11/08/2016 SUPPL-180 Labeling-Package Insert Label (PDF) 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 PHARMACIA AND UPJOHN
LINCOMYCIN LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201746 X-GEN PHARMS INC

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