Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 100MG | 0 | ATENOLOL | ATENOLOL |
002 | TABLET;ORAL | 25MG | 0 | ATENOLOL | ATENOLOL |
003 | TABLET;ORAL | 50MG | 0 | ATENOLOL | ATENOLOL |
FDA Submissions
| ORIG | 1 | AP | 1988-07-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1989-08-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-08-14 | |
LABELING; Labeling | SUPPL | 4 | AP | 1989-08-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1989-08-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-12-15 | |
LABELING; Labeling | SUPPL | 10 | AP | 1989-12-15 | |
LABELING; Labeling | SUPPL | 11 | AP | 1990-10-01 | |
LABELING; Labeling | SUPPL | 12 | AP | 1990-11-08 | |
LABELING; Labeling | SUPPL | 13 | AP | 1991-12-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1992-06-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1992-06-18 | |
LABELING; Labeling | SUPPL | 16 | AP | 1992-06-18 | |
LABELING; Labeling | SUPPL | 17 | AP | 1993-03-10 | |
LABELING; Labeling | SUPPL | 18 | AP | 1993-12-16 | |
LABELING; Labeling | SUPPL | 19 | AP | 1994-10-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-05-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1997-10-09 | |
LABELING; Labeling | SUPPL | 22 | AP | 1997-01-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-08-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-12-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2002-06-07 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
ALVOGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 72304
[companyName] => ALVOGEN
[docInserts] => ["",""]
[products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"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"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)