Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019529
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN BR INSULIN RECOMBINANT HUMAN 100 UNITS/ML 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
04/28/1986 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
02/10/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/26/1993 SUPPL-18 Labeling

Label is not available on this site.

12/07/1992 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/27/1992 SUPPL-16 Labeling

Label is not available on this site.

03/12/1991 SUPPL-15 Labeling

Label is not available on this site.

09/24/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1989 SUPPL-13 Labeling

Label is not available on this site.

01/23/1989 SUPPL-12 Labeling

Label is not available on this site.

05/26/1989 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

10/27/1987 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/13/1987 SUPPL-4 Labeling

Label is not available on this site.

07/28/1987 SUPPL-3 Labeling

Label is not available on this site.

09/15/1986 SUPPL-2 Labeling

Label is not available on this site.

05/28/1987 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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