ANDA 210771

PRINSTON PHARMA INC

FDA Drug Application

Application #210771

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 210771

PRINSTON PHARMA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	20MG	0	LEVOMILNACIPRAN	LEVOMILNACIPRAN
002	CAPSULE, EXTENDED RELEASE;ORAL	40MG	0	LEVOMILNACIPRAN	LEVOMILNACIPRAN
003	CAPSULE, EXTENDED RELEASE;ORAL	80MG	0	LEVOMILNACIPRAN	LEVOMILNACIPRAN
004	CAPSULE, EXTENDED RELEASE;ORAL	120MG	0	LEVOMILNACIPRAN	LEVOMILNACIPRAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PRINSTON PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210771
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-17
        )

)