Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 0.5MG BASE | 0 | VARENICLINE | VARENICLINE |
002 | TABLET;ORAL | EQ 1MG BASE | 0 | VARENICLINE | VARENICLINE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2021-08-11 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201785
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"VARENICLINE","activeIngredients":"VARENICLINE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARENICLINE","activeIngredients":"VARENICLINE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-08-11
)
)