Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 0.25MG/VIAL | 0 | OVIDREL | CHORIOGONADOTROPIN ALFA |
| 002 | INJECTABLE;SUBCUTANEOUS | EQ 0.25MG /0.5ML | 0 | OVIDREL | CHORIOGONADOTROPIN ALFA |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2003-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2007-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2013-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2010-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2012-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2012-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2013-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2013-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2013-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2013-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2013-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2013-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2013-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2013-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2013-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2014-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2015-09-30 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
CDER Filings
EMD SERONO
cder:Array
(
[0] => Array
(
[ApplNo] => 21149
[companyName] => EMD SERONO
[docInserts] => ["",""]
[products] => [{"drugName":"OVIDREL","activeIngredients":"CHORIOGONADOTROPIN ALFA","strength":"0.25MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OVIDREL","activeIngredients":"CHORIOGONADOTROPIN ALFA","strength":"EQ 0.25MG \/0.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/02\/2010","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021149s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2007","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021149s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21149lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OVIDREL","submission":"CHORIOGONADOTROPIN ALFA","actionType":"0.25MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OVIDREL","submission":"CHORIOGONADOTROPIN ALFA","actionType":"EQ 0.25MG \/0.5ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2010-06-02
)
)