Documents
Application Sponsors
| BLA 021273 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 75 IU/0.5ML | 0 | FOLLISTIM AQ | FOLLITROPIN ALFA/BETA |
| 002 | INJECTABLE;SUBCUTANEOUS | 150 IU/0.5ML | 0 | FOLLISTIM AQ | FOLLITROPIN ALFA/BETA |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-08-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2008-12-24 | N/A |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2010-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-11-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2015-09-10 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 31 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21273
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"FOLLISTIM AQ","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"75 IU\/0.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOLLISTIM AQ","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"150 IU\/0.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/28\/2010","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021273s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021273lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"FOLLISTIM AQ","submission":"FOLLITROPIN ALFA\/BETA","actionType":"75 IU\/0.5ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOLLISTIM AQ","submission":"FOLLITROPIN ALFA\/BETA","actionType":"150 IU\/0.5ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2010-06-28
)
)