Application Sponsors
| ANDA 078558 | AMNEAL PHARMS NY | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 400MG | 0 | IBUPROFEN | IBUPROFEN |
| 002 | TABLET;ORAL | 600MG | 0 | IBUPROFEN | IBUPROFEN |
| 003 | TABLET;ORAL | 800MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 2007-06-18 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2007-12-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2011-11-07 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2019-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 32 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 78558
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)