Application Sponsors
ANDA 209438 | HETERO LABS LTD III | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 30MG BASE | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
002 | CAPSULE;ORAL | EQ 45MG BASE | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
003 | CAPSULE;ORAL | EQ 75MG BASE | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-02-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 209438
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 45MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-02-23
)
)