Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Discontinued | 005 |
Application Products
| 001 | INJECTABLE;INJECTION | 6MG/VIAL | 0 | SAIZEN | SOMATROPIN |
| 002 | INJECTABLE;INJECTION | 5MG/VIAL | 0 | SAIZEN | SOMATROPIN |
| 003 | INJECTABLE;INJECTION | 8.8MG/VIAL | 0 | SAIZEN | SOMATROPIN |
| 005 | INJECTABLE;INJECTION | 4MG/VIAL | 0 | SAIZEN | SOMATROPIN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1996-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-01-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2000-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-03-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2000-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-07-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-07-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-09-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-12-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-10-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2004-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2003-07-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2004-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2007-01-16 | N/A |
| LABELING; Labeling | SUPPL | 34 | AP | 2007-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2007-10-31 | N/A |
| LABELING; Labeling | SUPPL | 37 | AP | 2007-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2007-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2012-04-03 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2013-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2013-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2013-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2013-01-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2013-01-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2013-01-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2013-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2013-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2013-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 2015-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 2013-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 2013-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2013-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2013-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 2013-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 2013-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 2013-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 71 | AP | 2013-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2014-06-18 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 2014-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 2014-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 2015-02-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 2015-03-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 2015-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 2017-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 2016-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 2016-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 86 | AP | 2017-05-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 7 | Null | 14 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 10 | Null | 14 |
| SUPPL | 11 | Null | 14 |
| SUPPL | 12 | Null | 14 |
| SUPPL | 13 | Null | 14 |
| SUPPL | 14 | Null | 14 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Null | 14 |
| SUPPL | 17 | Null | 14 |
| SUPPL | 18 | Null | 14 |
| SUPPL | 19 | Null | 14 |
| SUPPL | 25 | Null | 14 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 52 | Null | 14 |
| SUPPL | 53 | Null | 14 |
| SUPPL | 54 | Null | 14 |
| SUPPL | 56 | Null | 14 |
| SUPPL | 57 | Null | 14 |
| SUPPL | 58 | Null | 14 |
| SUPPL | 59 | Null | 14 |
| SUPPL | 60 | Null | 14 |
| SUPPL | 61 | Null | 14 |
| SUPPL | 62 | Null | 14 |
| SUPPL | 63 | Null | 14 |
| SUPPL | 64 | Null | 14 |
| SUPPL | 65 | Null | 14 |
| SUPPL | 66 | Null | 14 |
| SUPPL | 67 | Null | 14 |
| SUPPL | 69 | Null | 14 |
| SUPPL | 70 | Null | 14 |
| SUPPL | 71 | Null | 14 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 73 | Null | 14 |
| SUPPL | 74 | Null | 14 |
| SUPPL | 76 | Null | 14 |
| SUPPL | 77 | Null | 14 |
| SUPPL | 78 | Null | 14 |
| SUPPL | 80 | Null | 14 |
| SUPPL | 83 | Null | 6 |
| SUPPL | 86 | Null | 7 |
TE Codes
CDER Filings
EMD SERONO
cder:Array
(
[0] => Array
(
[ApplNo] => 19764
[companyName] => EMD SERONO
[docInserts] => ["",""]
[products] => [{"drugName":"SAIZEN","activeIngredients":"SOMATROPIN","strength":"6MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SAIZEN","activeIngredients":"SOMATROPIN","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SAIZEN","activeIngredients":"SOMATROPIN","strength":"8.8MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SAIZEN","activeIngredients":"SOMATROPIN","strength":"4MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/08\/2017","submission":"SUPPL-86","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019764s086lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2017","submission":"SUPPL-86","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019764s086lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2017","submission":"SUPPL-79","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019764s079lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/13\/2016","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019764s083lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2014","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019764s072lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2012","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019764s049lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2007","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2007","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2007","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2007","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s037lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2007","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s030lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2007","submission":"SUPPL-30","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019764s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2004","submission":"SUPPL-20","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19764s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2004","submission":"SUPPL-25","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19764scp,20604scp030_serostim_lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2003","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19764slr023_saizen_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SAIZEN","submission":"SOMATROPIN","actionType":"6MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SAIZEN","submission":"SOMATROPIN","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SAIZEN","submission":"SOMATROPIN","actionType":"8.8MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SAIZEN","submission":"SOMATROPIN","actionType":"4MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2017-05-08
)
)