Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 208751
Company: NOVO
Company: NOVO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FIASP | INSULIN ASPART | 1000 UNITS/10ML (100 UNITS/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
FIASP FLEXTOUCH | INSULIN ASPART | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
FIASP PENFILL | INSULIN ASPART | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;SUBCUTANEOUS | Prescription | 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 |
---|---|---|---|---|---|---|---|
09/29/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208751Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208751Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/21/2023 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208751Orig1s020ltr.pdf | |
10/21/2019 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s008, s013ltr.pdf | |
11/15/2019 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s012ltr.pdf | |
12/19/2019 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s010, s011ltr.pdf | |
12/19/2019 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s010, s011ltr.pdf | |
10/21/2019 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s008, s013ltr.pdf | |
09/04/2018 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
09/24/2018 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
07/22/2018 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
03/06/2018 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/21/2023 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf | |
06/21/2023 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf | |
06/21/2023 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf | |
12/19/2019 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf | |
12/19/2019 | SUPPL-10 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf | |
11/15/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf | |
11/15/2019 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf | |
10/21/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf | |
10/21/2019 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf | |
09/29/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf |