Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 0.25MG BASE/ML | 1 | CETROTIDE | CETRORELIX |
| 002 | INJECTABLE;INJECTION | EQ 3MG BASE/ML | 0 | CETROTIDE | CETRORELIX |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2000-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2004-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2004-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2008-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2013-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2013-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2013-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2017-12-22 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 18 | Null | 15 |
TE Codes
CDER Filings
EMD SERONO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21197
[companyName] => EMD SERONO INC
[docInserts] => ["",""]
[products] => [{"drugName":"CETROTIDE","activeIngredients":"CETRORELIX","strength":"EQ 0.25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CETROTIDE","activeIngredients":"CETRORELIX","strength":"EQ 3MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/04\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021197s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21197lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CETROTIDE","submission":"CETRORELIX","actionType":"EQ 0.25MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CETROTIDE","submission":"CETRORELIX","actionType":"EQ 3MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2008-04-04
)
)