Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 50MG | 1 | TENORMIN | ATENOLOL |
| 002 | TABLET;ORAL | 100MG | 1 | TENORMIN | ATENOLOL |
| 004 | TABLET;ORAL | 25MG | 1 | TENORMIN | ATENOLOL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1981-08-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1985-09-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1983-04-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1983-09-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 1989-09-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1983-12-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1984-07-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1984-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1985-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1987-02-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 1990-04-09 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1991-02-21 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1991-02-21 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1991-02-21 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1991-09-18 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1992-08-05 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1992-08-05 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1993-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1994-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 1996-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2000-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1999-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2003-01-09 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2003-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2005-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2008-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2011-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2012-10-31 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2015-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2015-07-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2015-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2015-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2015-09-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2015-09-10 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
ALVOGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 18240
[companyName] => ALVOGEN
[docInserts] => ["",""]
[products] => [{"drugName":"TENORMIN","activeIngredients":"ATENOLOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TENORMIN","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TENORMIN","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/31\/2012","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018240s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2011","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018240s031lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TENORMIN","submission":"ATENOLOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TENORMIN","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TENORMIN","submission":"ATENOLOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-10-31
)
)