Application Sponsors
| ANDA 074505 | HIKMA INTL PHARMS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 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 | 1996-02-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-01-31 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1997-01-31 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1998-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-10-25 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2000-10-25 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1999-08-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-06-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-10-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-08-10 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2011-07-22 | |
| LABELING; Labeling | SUPPL | 22 | AP | 2014-11-03 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2014-11-03 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2014-12-05 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2016-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2016-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2020-03-03 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 74505
[companyName] => HIKMA INTL PHARMS
[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
)
)