SUN PHARM INDS INC FDA Approval ANDA 213932

ANDA 213932

SUN PHARM INDS INC

FDA Drug Application

Application #213932

Application Sponsors

ANDA 213932SUN PHARM INDS INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

Application Products

001CAPSULE;ORALEQ 1.5MG BASE0CARIPRAZINE HYDROCHLORIDECARIPRAZINE HYDROCHLORIDE
002CAPSULE;ORALEQ 3MG BASE0CARIPRAZINE HYDROCHLORIDECARIPRAZINE HYDROCHLORIDE
003CAPSULE;ORALEQ 4.5MG BASE0CARIPRAZINE HYDROCHLORIDECARIPRAZINE HYDROCHLORIDE
004CAPSULE;ORALEQ 6MG BASE0CARIPRAZINE HYDROCHLORIDECARIPRAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-03-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213932
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARIPRAZINE HYDROCHLORIDE","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 1.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CARIPRAZINE HYDROCHLORIDE","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CARIPRAZINE HYDROCHLORIDE","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 4.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CARIPRAZINE HYDROCHLORIDE","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-09
        )

)

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