ANDA 213932

SUN PHARM INDS INC

FDA Drug Application

Application #213932

Documents

• Letter: 2022-08-09

Application Sponsors

ANDA 213932

SUN PHARM INDS INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 1.5MG BASE	0	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 3MG BASE	0	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 4.5MG BASE	0	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 6MG BASE	0	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-03-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

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
        )

)