Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050316
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINCOCIN LINCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
LINCOCIN LINCOMYCIN HYDROCHLORIDE EQ 500MG BASE CAPSULE;ORAL Discontinued None No 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
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
06/02/2004 SUPPL-99 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50317slr167,50316slr099ltr.pdf
10/30/2001 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

06/21/1985 SUPPL-96 Labeling

Label is not available on this site.

06/03/1985 SUPPL-95 Labeling

Label is not available on this site.

11/20/1982 SUPPL-94 Labeling

Label is not available on this site.

08/03/1982 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1982 SUPPL-92 Labeling

Label is not available on this site.

09/04/1981 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1980 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

10/15/1980 SUPPL-89 Labeling

Label is not available on this site.

08/06/1980 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1979 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1979 SUPPL-86 Labeling

Label is not available on this site.

03/30/1979 SUPPL-85 Labeling

Label is not available on this site.

07/10/1978 SUPPL-84 Labeling

Label is not available on this site.

06/26/1978 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1978 SUPPL-82 Labeling

Label is not available on this site.

06/29/1977 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

03/29/1977 SUPPL-80 Labeling

Label is not available on this site.

08/16/1976 SUPPL-79 Labeling

Label is not available on this site.

04/21/1976 SUPPL-78 Labeling

Label is not available on this site.

12/29/1975 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1975 SUPPL-76 Labeling

Label is not available on this site.

07/09/1976 SUPPL-75 Labeling

Label is not available on this site.

03/14/1975 SUPPL-74 Labeling

Label is not available on this site.

08/26/1974 SUPPL-73 Labeling

Label is not available on this site.

08/09/1974 SUPPL-72 Labeling

Label is not available on this site.

08/06/1974 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1974 SUPPL-70 Labeling

Label is not available on this site.

08/06/1974 SUPPL-69 Labeling

Label is not available on this site.

01/29/1974 SUPPL-68 Labeling

Label is not available on this site.

11/15/1973 SUPPL-67 Labeling

Label is not available on this site.

05/10/1973 SUPPL-66 Labeling

Label is not available on this site.

03/15/1973 SUPPL-65 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/05/1972 SUPPL-63 Labeling

Label is not available on this site.

07/31/1972 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1972 SUPPL-61 Labeling

Label is not available on this site.

10/14/1971 SUPPL-58 Labeling

Label is not available on this site.

09/27/1971 SUPPL-57 Labeling

Label is not available on this site.

09/23/1971 SUPPL-56 Labeling

Label is not available on this site.

07/22/1971 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1971 SUPPL-54 Labeling

Label is not available on this site.

05/27/1971 SUPPL-53 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/27/1971 SUPPL-52 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/10/1971 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1971 SUPPL-50 Labeling

Label is not available on this site.

02/08/1971 SUPPL-49 Labeling

Label is not available on this site.

12/09/1970 SUPPL-48 Labeling

Label is not available on this site.

11/18/1970 SUPPL-47 Labeling

Label is not available on this site.

09/10/1970 SUPPL-46 Labeling

Label is not available on this site.

09/04/1970 SUPPL-45 Labeling

Label is not available on this site.

08/07/1970 SUPPL-44 Labeling

Label is not available on this site.

08/21/1970 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/1970 SUPPL-42 Labeling

Label is not available on this site.

06/05/1970 SUPPL-41 Labeling

Label is not available on this site.

05/25/1970 SUPPL-40 Labeling

Label is not available on this site.

04/01/1970 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1970 SUPPL-38 Labeling

Label is not available on this site.

03/03/1970 SUPPL-37 Labeling

Label is not available on this site.

01/22/1970 SUPPL-35 Labeling

Label is not available on this site.

06/27/1969 SUPPL-34 Labeling

Label is not available on this site.

06/09/1969 SUPPL-33 Labeling

Label is not available on this site.

04/10/1969 SUPPL-32 Labeling

Label is not available on this site.

03/03/1969 SUPPL-31 Labeling

Label is not available on this site.

02/28/1969 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1970 SUPPL-29 Labeling

Label is not available on this site.

07/12/1968 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1968 SUPPL-27 Labeling

Label is not available on this site.

03/11/1968 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1968 SUPPL-25 Labeling

Label is not available on this site.

12/19/1967 SUPPL-24 Labeling

Label is not available on this site.

10/27/1967 SUPPL-23 Labeling

Label is not available on this site.

10/16/1967 SUPPL-22 Labeling

Label is not available on this site.

08/22/1967 SUPPL-21 Labeling

Label is not available on this site.

08/16/1967 SUPPL-20 Labeling

Label is not available on this site.

08/09/1967 SUPPL-19 Labeling

Label is not available on this site.

07/20/1967 SUPPL-18 Labeling

Label is not available on this site.

06/30/1967 SUPPL-17 Labeling

Label is not available on this site.

05/19/1967 SUPPL-16 Labeling

Label is not available on this site.

02/01/1967 SUPPL-15 Labeling

Label is not available on this site.

12/28/1966 SUPPL-14 Labeling

Label is not available on this site.

12/15/1966 SUPPL-13 Labeling

Label is not available on this site.

12/22/1966 SUPPL-12 Labeling

Label is not available on this site.

11/28/1966 SUPPL-10 Labeling

Label is not available on this site.

05/10/1966 SUPPL-9 Labeling

Label is not available on this site.

02/18/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/29/1991 SUPPL-7 Labeling

Label is not available on this site.

10/28/1998 SUPPL-6 Labeling

Label is not available on this site.

04/02/1965 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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