Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020100
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN 50/50 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 50 UNITS/ML;50 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
04/29/1992 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
07/31/2009 SUPPL-50

Label is not available on this site.

08/22/2007 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf
09/07/2007 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf
10/23/2003 SUPPL-21 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20100scm021ltr.pdf
08/29/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/09/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-3 Labeling

Label is not available on this site.

02/10/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/23/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2007 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf

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