ANDA 213984

ZYDUS PHARMS USA INC

FDA Drug Application

Application #213984

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 213984

ZYDUS PHARMS USA INC

Marketing Status

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

2021-12-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

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

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213984
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARIPRAZINE","activeIngredients":"CARIPRAZINE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-07
        )

)