Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019377
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN L INSULIN ZINC SUSP 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
09/30/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/09/2006 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019377s046,019571s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019377s046_019571s037ltr.pdf
04/18/2003 SUPPL-36 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19377scm036_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19377scm036ltr.pdf
08/29/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/09/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-15 Labeling

Label is not available on this site.

02/10/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/07/1992 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/27/1992 SUPPL-12 Labeling

Label is not available on this site.

03/12/1991 SUPPL-11 Labeling

Label is not available on this site.

09/24/1990 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1989 SUPPL-8 Labeling

Label is not available on this site.

07/29/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1988 SUPPL-6 Labeling

Label is not available on this site.

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

Label is not available on this site.

10/27/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/10/1987 SUPPL-3 Labeling

Label is not available on this site.

07/13/1987 SUPPL-2 Labeling

Label is not available on this site.

07/28/1987 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
01/09/2006 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019377s046,019571s037lbl.pdf
04/18/2003 SUPPL-36 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19377scm036_humulin_lbl.pdf

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