NDA 212595

SUN PHARM

FDA Drug Application

Application #212595

Documents

• Label: 2019-08-30
• Letter: 2019-08-30
• Review: 2020-02-11
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 212595

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION, EXTENDED RELEASE;ORAL

500MG/5ML

1

RIOMET ER

METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2019-08-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212595
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIOMET ER","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG\/5ML","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/29\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212595s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212595s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212595Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212595Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-08-29
        )

)