ANDA 202935

PAR PHARM

FDA Drug Application

Application #202935

Application Sponsors

ANDA 202935

PAR PHARM

Marketing Status

• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-15
REMS; REMS	SUPPL	3	AP	2018-09-18
LABELING; Labeling	SUPPL	4	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	8	Null	7
SUPPL	13	Null	7

TE Codes

002	Prescription	AA
003	Prescription	AA
004	Prescription	AA

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202935
            [companyName] => PAR PHARM
            [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\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-03-04
        )

)