Documents
Application Sponsors
| BLA 021810 | NOVO NORDISK INC | |
Marketing Status
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 50 UNITS/ML;50 UNITS/ML | 0 | NOVOLOG MIX 50/50 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2008-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-03-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2015-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2019-11-15 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 1 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 15 |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21810
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"NOVOLOG MIX 50\/50","activeIngredients":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","strength":"50 UNITS\/ML;50 UNITS\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021810ss018s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021810ss018s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021810ss018s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021810lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NOVOLOG MIX 50\/50","submission":"INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT","actionType":"50 UNITS\/ML;50 UNITS\/ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2019-11-15
)
)