ANDA 211044

TEVA PHARMS USA INC

FDA Drug Application

Application #211044

Application Sponsors

ANDA 211044

TEVA PHARMS USA INC

Marketing Status

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

Application Products

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

2022-03-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211044
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)