BLA 21810, held by Novo Nordisk Inc. Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant.
As of Nov 13, 2026, BLA 21810 (Novolog Mix 50/50), held by Novo Nordisk Inc, was first approved by FDA on Aug 26, 2008, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Novolog Mix 50/5050 UNITS/ML;50 UNITS/ML · injectable;subcutaneous | Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2019 | Supplement 19Labeling | Approved | |
| Nov 15, 2019 | Supplement 18Labeling · Standard review | Approved | |
| Aug 7, 2019 | Supplement 17Labeling · Standard review | Approved | |
| Feb 11, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Nov 21, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Feb 25, 2015 | Supplement 10Labeling | Approved | |
| Sep 4, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2013 | Supplement 4Labeling · Standard review | Approved | |
| Aug 26, 2008 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
