ANDA 208988

CADILA

FDA Drug Application

Application #208988

Application Sponsors

ANDA 208988

CADILA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	EQ 20MG BASE	0	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 40MG BASE	0	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 60MG BASE	0	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 80MG BASE	0	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

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

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208988
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 80MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/15\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-15
        )

)