Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | AMBRISENTAN | AMBRISENTAN |
| 002 | TABLET;ORAL | 10MG | 0 | AMBRISENTAN | AMBRISENTAN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-12-09 | STANDARD |
| REMS; REMS | SUPPL | 3 | AP | 2020-04-20 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-02-14 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2020-12-22 | |
| REMS; REMS | SUPPL | 6 | AP | 2021-06-08 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ZYDUS PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 210058
[companyName] => ZYDUS PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210058Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/14\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2020","submission":"SUPPL-3","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-20
)
)