ANDA 211499

ABHAI LLC

FDA Drug Application

Application #211499

Application Sponsors

ANDA 211499

ABHAI LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

325MG/5ML;5MG/5ML

0

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-31	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-03-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AA

CDER Filings

ABHAI LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211499
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG\/5ML;5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-07
        )

)