ANDA 211135

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #211135

Documents

• Letter: 2021-01-07

Application Sponsors

ANDA 211135

MSN LABORATORIES PRIVATE LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	0.5MG	0	RIOCIGUAT	RIOCIGUAT
002	TABLET;ORAL	1MG	0	RIOCIGUAT	RIOCIGUAT
003	TABLET;ORAL	1.5MG	0	RIOCIGUAT	RIOCIGUAT
004	TABLET;ORAL	2MG	0	RIOCIGUAT	RIOCIGUAT
005	TABLET;ORAL	2.5MG	0	RIOCIGUAT	RIOCIGUAT

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-11-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

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

CDER Filings

MSN LABORATORIES PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211135
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)