Application Sponsors
| ANDA 091633 | SUN PHARM INDS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 2.5MG;200MG | 0 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN |
| 002 | TABLET;ORAL | 5MG;200MG | 0 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN |
| 003 | TABLET;ORAL | 7.5MG;200MG | 0 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN |
| 004 | TABLET;ORAL | 10MG;200MG | 0 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 2013-05-28 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-09-14 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-05-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91633
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"2.5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"7.5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"10MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"2.5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"7.5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"10MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)