Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 75 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
| 002 | INJECTABLE;SUBCUTANEOUS | 150 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
| 003 | INJECTABLE;SUBCUTANEOUS | 37.5 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
| 004 | INJECTABLE;SUBCUTANEOUS | 1,050 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
| 005 | INJECTABLE;SUBCUTANEOUS | 450 IU/VIAL | 0 | GONAL-F | FOLLITROPIN ALFA/BETA |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-09-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-05-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-01-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2000-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-11-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-08-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-03-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2004-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-07-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2003-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2003-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2013-08-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2015-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2020-12-31 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2013-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2013-02-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2013-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2013-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2013-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2013-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2013-02-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2013-02-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2013-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2016-02-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2013-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2013-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2014-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 2013-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 2013-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 2013-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2014-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2020-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 2015-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 2015-03-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 2016-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2020-12-31 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | 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 | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | 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 | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 67 | Null | 15 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 75 | Null | 7 |
CDER Filings
EMD SERONO
cder:Array
(
[0] => Array
(
[ApplNo] => 20378
[companyName] => EMD SERONO
[docInserts] => ["",""]
[products] => [{"drugName":"GONAL-F","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"75 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","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":"1,050 IU\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GONAL-F","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"450 IU\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/31\/2020","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020378s045,s067,s075lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2020","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020378s045,s067,s075lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2020","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020378s045,s067,s075lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2004","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20378scf015_gonal_lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2000","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/20-378S-006_review.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"GONAL-F","submission":"FOLLITROPIN ALFA\/BETA","actionType":"75 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","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":"1,050 IU\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GONAL-F","submission":"FOLLITROPIN ALFA\/BETA","actionType":"450 IU\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2020-12-31
)
)