ANDA 210805

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #210805

Documents

• Letter: 2020-08-21

Application Sponsors

ANDA 210805

MSN LABORATORIES PRIVATE LTD

Marketing Status

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

Application Products

001	UNKNOWN	UNKNOWN	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

2020-06-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210805
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-01
        )

)