Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205747
Company: ELI LILLY AND CO
Company: ELI LILLY AND CO
| 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 | Yes | Yes |
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 | Type 5 - New Formulation or New Manufacturer | STANDARD |
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 |
|---|---|---|---|---|---|
| 11/15/2019 | SUPPL-26 | Labeling-Package Insert |
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 | Labeling-Container/Carton Labels |
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 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
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 | Labeling-Patient Package Insert |
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 | Labeling-Package Insert |
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 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 | Labeling-Package Insert |
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 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/2015 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 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-Patient Package Insert | 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 | |
| 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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