Application Sponsors
| ANDA 204165 | SCIEGEN PHARMS INC | |
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
| UNKNOWN; | ORIG | 1 | AP | 2014-09-15 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2023-01-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 31 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 25 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204165
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/15\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-13
)
)