Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 37.5 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
| 002 | INJECTABLE;SUBCUTANEOUS | 75 IU/VIAL | 0 | GONAL-F RFF | FOLLITROPIN ALFA/BETA |
| 003 | INJECTABLE;SUBCUTANEOUS | 150 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2004-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2005-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2007-07-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2015-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2020-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-12-31 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2013-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2013-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2013-02-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2013-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2013-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2013-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2013-02-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2013-02-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2013-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2013-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2013-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2014-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2015-04-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2016-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2020-12-31 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 44 | Null | 6 |
CDER Filings
EMD SERONO
cder:Array
(
[0] => Array
(
[ApplNo] => 21765
[companyName] => EMD SERONO
[docInserts] => ["",""]
[products] => [{"drugName":"GONAL-F","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"37.5 IU\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GONAL-F","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"150 IU\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GONAL-F RFF","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"75 IU\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/31\/2020","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021765s013s014s044lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021765s013s014s044lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020021765s013s014s044lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021765s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2005","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021765s004lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/25\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21765_follitropin_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"GONAL-F","submission":"FOLLITROPIN ALFA\/BETA","actionType":"37.5 IU\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GONAL-F","submission":"FOLLITROPIN ALFA\/BETA","actionType":"150 IU\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GONAL-F RFF","submission":"FOLLITROPIN ALFA\/BETA","actionType":"75 IU\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2020-12-31
)
)