Application Sponsors
ANDA 077443 | UNIQUE PHARM LABS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | ATENOLOL | ATENOLOL |
002 | TABLET;ORAL | 50MG | 0 | ATENOLOL | ATENOLOL |
003 | TABLET;ORAL | 100MG | 0 | ATENOLOL | ATENOLOL |
FDA Submissions
| ORIG | 1 | AP | 2006-09-13 | |
LABELING; Labeling | SUPPL | 2 | AP | 2010-07-06 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-11-28 | |
LABELING; Labeling | SUPPL | 5 | AP | 2014-11-04 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 5 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 77443
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)