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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 205747
Company: ELI LILLY AND CO

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 205747

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HUMALOG KWIKPEN	INSULIN LISPRO RECOMBINANT	200 UNITS/ML	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 205747

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205747s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205747Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205747Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2023	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020563Orig1s202,021017Orig1s146,021018Orig1s132,205747Orig1s028ltr.pdf
11/15/2019	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s196, s198, s199; 205747Orig1s022, 025, 026ltr.pdf
11/15/2019	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s196, s198, s199; 205747Orig1s022, 025, 026ltr.pdf
11/15/2019	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s196, s198, s199; 205747Orig1s022, 025, 026ltr.pdf
08/13/2019	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s195, 205747Orig1s021ltr.pdf
11/01/2018	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020563orig1s191,205747Orig1s018ltr.pdf
06/06/2017	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205747s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205747Orig1s010ltr.pdf
01/06/2017	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s172,205747s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf
08/05/2016	SUPPL-6	Supplement		Label is not available on this site.
11/25/2015	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 205747

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2023	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf
07/21/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf
07/21/2023	SUPPL-28	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf
11/15/2019	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf
11/15/2019	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf
11/15/2019	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf
11/15/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf
11/15/2019	SUPPL-22	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf
08/13/2019	SUPPL-21	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf
11/01/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf
06/06/2017	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205747s010lbl.pdf
06/06/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205747s010lbl.pdf
01/06/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s172,205747s008lbl.pdf
05/26/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205747s000lbl.pdf

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