ANDA 211708

GRANULES PHARMS

FDA Drug Application

Application #211708

Application Sponsors

ANDA 211708

GRANULES PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	325MG;2.5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
002	TABLET;ORAL	325MG;5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
003	TABLET;ORAL	325MG;7.5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
004	TABLET;ORAL	325MG;10MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-31

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA
004	Prescription	AA

CDER Filings

GRANULES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211708
            [companyName] => GRANULES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-31
        )

)