Documents
Application Sponsors
| BLA 019938 | NOVO NORDISK INC | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 100 UNITS/ML | 0 | NOVOLIN R | INSULIN RECOMBINANT HUMAN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1991-06-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1992-03-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1993-03-26 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1994-01-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-05-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1994-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1994-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1994-01-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1995-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-08-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1997-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1996-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1997-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1997-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1997-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-08-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-07-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2000-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2000-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2001-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2002-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2001-01-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2002-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2002-04-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2001-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2002-01-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2002-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2005-11-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 48 | AP | 2005-10-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 63 | AP | 2009-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 2009-07-17 | N/A |
| LABELING; Labeling | SUPPL | 66 | AP | 2012-02-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 2010-06-25 | N/A |
| LABELING; Labeling | SUPPL | 68 | AP | 2010-12-27 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2010-06-25 | UNKNOWN |
| LABELING; Labeling | SUPPL | 71 | AP | 2013-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2013-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 2015-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2016-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 2016-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 76 | AP | 2018-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2019-11-15 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 82 | AP | 2022-11-23 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 48 | Null | 31 |
| SUPPL | 64 | Null | 4 |
| SUPPL | 66 | Null | 15 |
| SUPPL | 67 | Null | 6 |
| SUPPL | 68 | Null | 6 |
| SUPPL | 69 | Null | 6 |
| SUPPL | 71 | Null | 15 |
| SUPPL | 72 | Null | 15 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 74 | Null | 15 |
| SUPPL | 76 | Null | 15 |
| SUPPL | 79 | Null | 6 |
| SUPPL | 82 | Null | 6 |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19938
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"NOVOLIN R","activeIngredients":"INSULIN RECOMBINANT HUMAN","strength":"100 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NOVOLIN R","submission":"INSULIN RECOMBINANT HUMAN","actionType":"100 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)