Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | 12.5MG | 0 | CAPTOPRIL | CAPTOPRIL |
002 | TABLET;ORAL | 25MG | 0 | CAPTOPRIL | CAPTOPRIL |
003 | TABLET;ORAL | 50MG | 0 | CAPTOPRIL | CAPTOPRIL |
004 | TABLET;ORAL | 100MG | 0 | CAPTOPRIL | CAPTOPRIL |
FDA Submissions
| ORIG | 1 | AP | 1998-10-28 | |
LABELING; Labeling | SUPPL | 5 | AP | 2007-11-13 | |
LABELING; Labeling | SUPPL | 7 | AP | 2011-04-08 | |
LABELING; Labeling | SUPPL | 8 | AP | 2015-01-20 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2016-02-16 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2016-02-16 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2020-03-03 | STANDARD |
Submissions Property Types
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 15 |
SUPPL | 11 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
ANNORA PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 74737
[companyName] => ANNORA PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)