Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Discontinued | 006 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | 0 | NUTROPIN AQ | SOMATROPIN |
| 002 | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | 0 | NUTROPIN AQ PEN | SOMATROPIN |
| 003 | INJECTABLE;INJECTION | 5MG/2ML (2.5MG/ML) | 0 | NUTROPIN AQ NUSPIN | SOMATROPIN |
| 004 | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | 0 | NUTROPIN AQ NUSPIN | SOMATROPIN |
| 005 | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | 0 | NUTROPIN AQ NUSPIN | SOMATROPIN |
| 006 | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | 0 | NUTROPIN AQ PEN | SOMATROPIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1995-12-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1997-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-09-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 1997-12-17 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-09-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-09-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 1999-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-11-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1999-11-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-10-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2000-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-04-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2005-06-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 22 | AP | 2005-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2008-01-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2005-11-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 33 | AP | 2007-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2008-01-03 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2008-01-03 | N/A |
| LABELING; Labeling | SUPPL | 45 | AP | 2012-04-10 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2013-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2013-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2014-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2014-05-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2015-05-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2015-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2016-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2016-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2016-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2016-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2016-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2016-12-13 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 61 | Null | 15 |
CDER Filings
GENENTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 20522
[companyName] => GENENTECH
[docInserts] => ["",""]
[products] => [{"drugName":"NUTROPIN AQ","activeIngredients":"SOMATROPIN","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NUTROPIN AQ NUSPIN","activeIngredients":"SOMATROPIN","strength":"5MG\/2ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NUTROPIN AQ NUSPIN","activeIngredients":"SOMATROPIN","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NUTROPIN AQ NUSPIN","activeIngredients":"SOMATROPIN","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NUTROPIN AQ PEN","activeIngredients":"SOMATROPIN","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NUTROPIN AQ PEN","activeIngredients":"SOMATROPIN","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NUTROPIN AQ","submission":"SOMATROPIN","actionType":"10MG\/2ML (5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NUTROPIN AQ NUSPIN","submission":"SOMATROPIN","actionType":"5MG\/2ML (2.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NUTROPIN AQ NUSPIN","submission":"SOMATROPIN","actionType":"20MG\/2ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NUTROPIN AQ NUSPIN","submission":"SOMATROPIN","actionType":"10MG\/2ML (5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NUTROPIN AQ PEN","submission":"SOMATROPIN","actionType":"10MG\/2ML (5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NUTROPIN AQ PEN","submission":"SOMATROPIN","actionType":"20MG\/2ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)