NDA 212895

CSPC OUYI

FDA Drug Application

Application #212895

Documents

• Label: 2019-12-20
• Letter: 2019-12-23
• Review: 2020-04-27
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 212895

CSPC OUYI

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 1.25MG BASE	1	CONJUPRI	LEVAMLODIPINE MALEATE
002	TABLET;ORAL	EQ 2.5MG BASE	1	CONJUPRI	LEVAMLODIPINE MALEATE
003	TABLET;ORAL	EQ 5MG BASE	1	CONJUPRI	LEVAMLODIPINE MALEATE

FDA Submissions

TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage Form

ORIG

1

AP

2019-12-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

CSPC OUYI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212895
            [companyName] => CSPC OUYI
            [docInserts] => ["",""]
            [products] => [{"drugName":"CONJUPRI","activeIngredients":"LEVAMLODIPINE MALEATE","strength":"EQ 1.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CONJUPRI","activeIngredients":"LEVAMLODIPINE MALEATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"CONJUPRI","activeIngredients":"LEVAMLODIPINE MALEATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/19\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212895s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient and Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212895s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212895Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212895Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-19
        )

)