Application Sponsors
ANDA 212796 | DR REDDYS LABS SA | |
Marketing Status
Over-the-counter | 001 |
Over-the-counter | 002 |
Application Products
001 | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | 0 | NICOTINE POLACRILEX | NICOTINE POLACRILEX |
002 | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | 0 | NICOTINE POLACRILEX | NICOTINE POLACRILEX |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-01-08 | STANDARD |
Submissions Property Types
CDER Filings
DR REDDYS LABS SA
cder:Array
(
[0] => Array
(
[ApplNo] => 212796
[companyName] => DR REDDYS LABS SA
[docInserts] => ["",""]
[products] => [{"drugName":"NICOTINE POLACRILEX","activeIngredients":"NICOTINE POLACRILEX","strength":"EQ 2MG BASE","dosageForm":"TROCHE\/LOZENGE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"NICOTINE POLACRILEX","activeIngredients":"NICOTINE POLACRILEX","strength":"EQ 4MG BASE","dosageForm":"TROCHE\/LOZENGE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-01-08
)
)