Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019571
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN U INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN 40 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HUMULIN U INSULIN ZINC SUSP EXTENDED 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
06/10/1987 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
01/09/2006 SUPPL-37 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-29 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19571scm029_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19571scm029ltr.pdf
08/29/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1997 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1996 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/09/1995 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-14 Labeling

Label is not available on this site.

02/10/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/27/1992 SUPPL-11 Labeling

Label is not available on this site.

03/12/1991 SUPPL-10 Labeling

Label is not available on this site.

09/24/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1989 SUPPL-6 Labeling

Label is not available on this site.

07/29/1988 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1988 SUPPL-4 Labeling

Label is not available on this site.

10/27/1987 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1987 SUPPL-2 Manufacturing (CMC)

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-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019377s046,019571s037lbl.pdf
04/18/2003 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19571scm029_humulin_lbl.pdf

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