Application Sponsors
ANDA 040746 | AMNEAL PHARMS NY | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 325MG;10MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
002 | TABLET;ORAL | 325MG;7.5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 2006-08-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2013-04-26 | |
LABELING; Labeling | SUPPL | 10 | AP | 2011-06-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2016-05-10 | |
LABELING; Labeling | SUPPL | 13 | AP | 2014-06-23 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2015-07-02 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2016-12-16 | STANDARD |
REMS; REMS | SUPPL | 20 | AP | 2018-09-18 | |
LABELING; Labeling | SUPPL | 21 | AP | 2018-09-21 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2019-10-10 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 8 | Null | 15 |
SUPPL | 10 | Null | 7 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 15 |
SUPPL | 15 | Null | 15 |
SUPPL | 17 | Null | 7 |
SUPPL | 18 | Null | 15 |
SUPPL | 20 | Null | 7 |
SUPPL | 21 | Null | 15 |
SUPPL | 23 | Null | 15 |
SUPPL | 29 | Null | 7 |
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 40746
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)