ANDA 040894

GENUS

FDA Drug Application

Application #040894

Application Sponsors

ANDA 040894

GENUS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

325MG/15ML;7.5MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2011-07-19
LABELING; Labeling	SUPPL	2	AP	2016-01-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	10	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2022-04-20	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7
SUPPL	21	Null	7

TE Codes

001

Prescription

AA

CDER Filings

GENUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40894
            [companyName] => GENUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG\/15ML;7.5MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG\/15ML;7.5MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)