Application Sponsors
ANDA 040778 | AMNEAL PHARMS NY | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 325MG;10MG | 0 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
002 | TABLET;ORAL | 325MG;7.5MG | 0 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2007-11-27 | |
LABELING; Labeling | SUPPL | 6 | AP | 2011-06-29 | |
LABELING; Labeling | SUPPL | 9 | AP | 2013-10-18 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2016-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2018-09-21 | STANDARD |
REMS; REMS | SUPPL | 16 | AP | 2018-09-18 | |
LABELING; Labeling | SUPPL | 19 | AP | 2019-10-07 | STANDARD |
Submissions Property Types
SUPPL | 6 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 11 | Null | 7 |
SUPPL | 13 | Null | 7 |
SUPPL | 14 | Null | 7 |
SUPPL | 15 | Null | 15 |
SUPPL | 16 | Null | 15 |
SUPPL | 19 | Null | 7 |
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 40778
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;10MG","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"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;10MG","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"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)