Documents
Application Sponsors
| BLA 021148 | NOVO NORDISK INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
| Prescription | 008 |
| Prescription | 009 |
| Prescription | 010 |
| Prescription | 011 |
Application Products
| 001 | INJECTABLE;INJECTION | 5MG/1.5ML | 0 | NORDITROPIN | SOMATROPIN |
| 002 | INJECTABLE;INJECTION | 10MG/1.5ML | 0 | NORDITROPIN | SOMATROPIN |
| 003 | INJECTABLE;INJECTION | 15MG/1.5ML | 0 | NORDITROPIN | SOMATROPIN |
| 004 | INJECTABLE;INJECTION | 5MG/1.5ML | 0 | NORDITROPIN NORDIFLEX | SOMATROPIN |
| 005 | INJECTABLE;INJECTION | 10MG/1.5ML | 0 | NORDITROPIN NORDIFLEX | SOMATROPIN |
| 006 | INJECTABLE;INJECTION | 15MG/1.5ML | 0 | NORDITROPIN NORDIFLEX | SOMATROPIN |
| 007 | INJECTABLE;INJECTION | 30MG/3ML | 0 | NORDITROPIN NORDIFLEX | SOMATROPIN |
| 008 | INJECTABLE;INJECTION | 5MG/1.5ML | 0 | NORDITROPIN FLEXPRO | SOMATROPIN |
| 009 | INJECTABLE;INJECTION | 10MG/1.5ML | 0 | NORDITROPIN FLEXPRO | SOMATROPIN |
| 010 | INJECTABLE;INJECTION | 15MG/1.5ML | 0 | NORDITROPIN FLEXPRO | SOMATROPIN |
| 011 | INJECTABLE;INJECTION | 30MG/3ML | 0 | NORDITROPIN FLEXPRO | SOMATROPIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-08-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2005-04-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2004-10-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2004-11-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 2006-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2007-02-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2007-05-31 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2007-09-20 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2007-09-14 | N/A |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2008-10-31 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2009-03-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2010-03-01 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2015-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2011-05-25 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2018-02-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 38 | AP | 2018-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2013-10-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2013-05-15 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2014-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2015-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2015-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2015-07-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2016-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2016-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2017-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2016-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2017-08-29 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2020-03-09 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 37 | Null | 12 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 15 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 48 | Null | 15 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 53 | Null | 6 |
TE Codes
| 008 | Prescription | |
| 009 | Prescription | |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21148
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"NORDITROPIN","activeIngredients":"SOMATROPIN","strength":"5MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN","activeIngredients":"SOMATROPIN","strength":"10MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN","activeIngredients":"SOMATROPIN","strength":"15MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN FLEXPRO","activeIngredients":"SOMATROPIN","strength":"5MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN FLEXPRO","activeIngredients":"SOMATROPIN","strength":"10MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN FLEXPRO","activeIngredients":"SOMATROPIN","strength":"15MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN FLEXPRO","activeIngredients":"SOMATROPIN","strength":"30MG\/3ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN NORDIFLEX","activeIngredients":"SOMATROPIN","strength":"5MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN NORDIFLEX","activeIngredients":"SOMATROPIN","strength":"10MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN NORDIFLEX","activeIngredients":"SOMATROPIN","strength":"15MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORDITROPIN NORDIFLEX","activeIngredients":"SOMATROPIN","strength":"30MG\/3ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NORDITROPIN","submission":"SOMATROPIN","actionType":"5MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN","submission":"SOMATROPIN","actionType":"10MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN","submission":"SOMATROPIN","actionType":"15MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN FLEXPRO","submission":"SOMATROPIN","actionType":"5MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN FLEXPRO","submission":"SOMATROPIN","actionType":"10MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN FLEXPRO","submission":"SOMATROPIN","actionType":"15MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN FLEXPRO","submission":"SOMATROPIN","actionType":"30MG\/3ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN NORDIFLEX","submission":"SOMATROPIN","actionType":"5MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN NORDIFLEX","submission":"SOMATROPIN","actionType":"10MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN NORDIFLEX","submission":"SOMATROPIN","actionType":"15MG\/1.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORDITROPIN NORDIFLEX","submission":"SOMATROPIN","actionType":"30MG\/3ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)