NDA 214869

RIVERSIDE PHARMA CORP

FDA Drug Application

Application #214869

Documents

• Label: 2021-11-15
• Letter: 2021-11-16
• Review: 2022-05-31
• Letter: 2022-07-01
• Label: 2022-07-05
• Letter: 2022-07-29
• Label: 2022-08-02

Application Sponsors

NDA 214869

RIVERSIDE PHARMA CORP

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG;100MG

0

DHIVY

CARBIDOPA;LEVODOPA

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2021-11-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-06-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-07-28	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6
SUPPL	3	Null	15

CDER Filings

RIVERSIDE PHARMA CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214869
            [companyName] => RIVERSIDE PHARMA CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"DHIVY","activeIngredients":"CARBIDOPA;LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/12\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214869s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214869s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214869Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-12
        )

)