Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 75MG BASE | 0 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE |
002 | TABLET;ORAL | EQ 300MG BASE | 0 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE |
FDA Submissions
| ORIG | 1 | AP | 2012-08-14 | |
| ORIG | 2 | AP | 2012-11-20 | |
LABELING; Labeling | SUPPL | 4 | AP | 2015-12-11 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2020-03-24 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-03-24 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-03-24 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2021-12-21 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2022-11-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
ORIG | 2 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
CELLTRION
cder:Array
(
[0] => Array
(
[ApplNo] => 202266
[companyName] => CELLTRION
[docInserts] => ["",""]
[products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/20\/2012","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/24\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-24
)
)