Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050482
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFLIN CEPHALOTHIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFLIN CEPHALOTHIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFLIN CEPHALOTHIN SODIUM EQ 4GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFLIN CEPHALOTHIN SODIUM EQ 20GM BASE/VIAL INJECTABLE;INJECTION 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
12/18/1974 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/1993 SUPPL-27 Labeling

Label is not available on this site.

03/20/1987 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1986 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1985 SUPPL-19 Labeling

Label is not available on this site.

11/25/1985 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

06/07/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1985 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1983 SUPPL-13 Labeling

Label is not available on this site.

10/05/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1983 SUPPL-11 Labeling

Label is not available on this site.

08/05/1983 SUPPL-10 Labeling

Label is not available on this site.

08/05/1983 SUPPL-9 Labeling

Label is not available on this site.

06/21/1983 SUPPL-8 Labeling

Label is not available on this site.

06/20/1983 SUPPL-7 Labeling

Label is not available on this site.

03/18/1983 SUPPL-6 Labeling

Label is not available on this site.

03/08/1983 SUPPL-5 Labeling

Label is not available on this site.

02/17/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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