Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 150MG BASE | 0 | ALISKIREN HEMIFUMARATE | ALISKIREN HEMIFUMARATE |
002 | TABLET;ORAL | EQ 300MG BASE | 0 | ALISKIREN HEMIFUMARATE | ALISKIREN HEMIFUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-03-22 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ANCHEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 206665
[companyName] => ANCHEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ALISKIREN HEMIFUMARATE","activeIngredients":"ALISKIREN HEMIFUMARATE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALISKIREN HEMIFUMARATE","activeIngredients":"ALISKIREN HEMIFUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206665Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-03-22
)
)