ANDA 209037

ABHAI LLC

FDA Drug Application

Application #209037

Application Sponsors

ANDA 209037

ABHAI LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	325MG;5MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE
002	TABLET;ORAL	325MG;7.5MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE
003	TABLET;ORAL	325MG;10MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

CDER Filings

ABHAI LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209037
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;5MG","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"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-11
        )

)