Application Sponsors
ANDA 077454 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 5MG;200MG | 0 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 2010-06-23 | |
LABELING; Labeling | SUPPL | 2 | AP | 2018-09-21 | STANDARD |
REMS; REMS | SUPPL | 3 | AP | 2018-09-18 | |
LABELING; Labeling | SUPPL | 4 | AP | 2019-07-22 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2019-10-11 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-03-04 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 15 |
CDER Filings
ANI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 77454
[companyName] => ANI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)