Application Sponsors
| ANDA 080975 | HIKMA INTL PHARMS | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 0.1MG | 0 | RESERPINE | RESERPINE |
| 002 | TABLET;ORAL | 0.25MG | 0 | RESERPINE | RESERPINE |
| 003 | TABLET;ORAL | 1MG | 0 | RESERPINE | RESERPINE |
FDA Submissions
| ORIG | 1 | AP | 1972-12-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1982-04-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1984-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1991-02-08 | |
Submissions Property Types
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 16 | Null | 0 |
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 80975
[companyName] => HIKMA INTL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"RESERPINE","activeIngredients":"RESERPINE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RESERPINE","activeIngredients":"RESERPINE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RESERPINE","activeIngredients":"RESERPINE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RESERPINE","submission":"RESERPINE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RESERPINE","submission":"RESERPINE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RESERPINE","submission":"RESERPINE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)