ANDA 212133

ASCENT PHARMS INC

FDA Drug Application

Application #212133

Application Sponsors

ANDA 212133

ASCENT PHARMS INC

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	8MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	12MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	16MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	32MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212133
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"12MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"16MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"32MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-23
        )

)