Documents
Application Sponsors
| BLA 021172 | NOVO NORDISK INC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML) | 0 | NOVOLOG MIX 70/30 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
| 002 | INJECTABLE;SUBCUTANEOUS | 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | 0 | NOVOLOG MIX 70/30 PENFILL | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
| 003 | INJECTABLE;SUBCUTANEOUS | 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | 0 | NOVOLOG MIX 70/30 PENFILL | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
| 004 | INJECTABLE;SUBCUTANEOUS | 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | 0 | NOVOLOG MIX 70/30 FLEXPEN | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2001-11-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-07-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-11-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-11-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-12-04 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2004-10-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2005-11-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2005-11-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2007-07-20 | N/A |
| LABELING; Labeling | SUPPL | 38 | AP | 2008-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2008-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2008-11-28 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2009-05-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2010-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2015-02-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 49 | AP | 2010-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2012-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2013-03-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2014-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2017-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2015-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 64 | AP | 2015-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 68 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2019-11-15 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 74 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 45 | Null | 31 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 49 | Null | 7 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 15 |
| SUPPL | 63 | Null | 6 |
| SUPPL | 64 | Null | 6 |
| SUPPL | 68 | Null | 33 |
| SUPPL | 71 | Null | 15 |
| SUPPL | 72 | Null | 6 |
| SUPPL | 74 | Null | 6 |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21172
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"NOVOLOG MIX 70\/30","activeIngredients":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","strength":"700 UNITS\/10ML; 300 UNITS\/10ML (70 UNITS\/ML; 30 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG MIX 70\/30 FLEXPEN","activeIngredients":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","strength":"210 UNITS\/3ML; 90 UNITS\/3ML (70 UNITS\/ML; 30 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG MIX 70\/30 PENFILL","activeIngredients":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","strength":"210 UNITS\/3ML;90 UNITS\/3ML (70 UNITS\/ML; 30 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG MIX 70\/30 PENFILL","activeIngredients":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","strength":"210 UNITS\/3ML;90 UNITS\/3ML (70 UNITS\/ML; 30 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021172s071s072lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-71","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021172s071s072lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021172s071s072lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21172_Novolog_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NOVOLOG MIX 70\/30","submission":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","actionType":"700 UNITS\/10ML; 300 UNITS\/10ML (70 UNITS\/ML; 30 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG MIX 70\/30 FLEXPEN","submission":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","actionType":"210 UNITS\/3ML; 90 UNITS\/3ML (70 UNITS\/ML; 30 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG MIX 70\/30 PENFILL","submission":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","actionType":"210 UNITS\/3ML;90 UNITS\/3ML (70 UNITS\/ML; 30 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG MIX 70\/30 PENFILL","submission":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","actionType":"210 UNITS\/3ML;90 UNITS\/3ML (70 UNITS\/ML; 30 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2019-11-15
)
)