Application Sponsors
| ANDA 090535 | SUN PHARM INDS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 325MG;2.5MG | 0 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 325MG;5MG | 0 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 325MG;7.5MG | 0 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 325MG;10MG | 0 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2013-12-26 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2018-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
| 003 | Prescription | AA |
| 004 | Prescription | AA |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90535
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)