ANDA 216030

ASCENT PHARMS INC

FDA Drug Application

Application #216030

Application Sponsors

ANDA 216030

ASCENT PHARMS INC

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	TABLET;ORAL	10MG	0	FAMOTIDINE	FAMOTIDINE
002	TABLET;ORAL	20MG	0	FAMOTIDINE	FAMOTIDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216030
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-03
        )

)