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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 018780
Company: LILLY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter None No No
HUMULIN R INSULIN HUMAN 10000 UNITS/20ML (500 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No No
HUMULIN R KWIKPEN INSULIN HUMAN 1500 UNITS/3ML (500 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No No
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/27/2022 SUPPL-180 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf
06/27/2022 SUPPL-180 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf
06/27/2022 SUPPL-180 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf
11/15/2019 SUPPL-176 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf
11/15/2019 SUPPL-175 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf
11/15/2019 SUPPL-175 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf
08/22/2019 SUPPL-172 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf
08/22/2019 SUPPL-172 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf
08/22/2019 SUPPL-172 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf
11/06/2018 SUPPL-168 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s168lbl.pdf
05/25/2018 SUPPL-126 Manufacturing (CMC) Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s126s134lbl.pdf
07/08/2016 SUPPL-153 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf
07/08/2016 SUPPL-153 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf
12/29/2015 SUPPL-152 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
12/29/2015 SUPPL-152 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
12/29/2015 SUPPL-152 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
12/29/2015 SUPPL-135 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
02/25/2015 SUPPL-150 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf
02/25/2015 SUPPL-150 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf
09/23/2014 SUPPL-148 Manufacturing (CMC) Label (PDF) Label for HUMULIN R U-500 This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf
03/09/2013 SUPPL-132 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf
03/09/2013 SUPPL-132 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf
03/25/2011 SUPPL-120 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf
06/10/2010 SUPPL-128 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018780s128lbl.pdf
09/10/2007 SUPPL-114 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf
08/22/2007 SUPPL-95 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf
02/25/2005 SUPPL-86 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf
11/10/2003 SUPPL-80 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf
02/10/2003 SUPPL-78 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf
02/10/2003 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf
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