Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021810
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NOVOLOG MIX 50/50 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | 50 UNITS/ML;50 UNITS/ML | INJECTABLE;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
08/26/2008 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021810s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810_novolog_mix_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810S000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/15/2019 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf | |
11/15/2019 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf | |
08/07/2019 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021810Orig1s017ltr.pdf | |
02/11/2019 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021810Orig1s015ltr.pdf | |
02/25/2015 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021810Orig1s010ltr.pdf | |
09/04/2014 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
03/09/2013 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021810Orig1s004ltr.pdf | |
11/21/2017 | SUPPL-1 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/15/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf | |
11/15/2019 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf | |
11/15/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf | |
08/07/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s017lbl.pdf | |
02/11/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s015lbl.pdf | |
11/21/2017 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf | |
02/25/2015 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf | |
03/09/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf | |
03/09/2013 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf | |
08/26/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf |