ANDA 077560

LUPIN PHARMS

FDA Drug Application

Application #077560

Documents

• Letter: 2007-05-29

Application Sponsors

ANDA 077560

LUPIN PHARMS

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

	ORIG	1	AP	2012-03-02
LABELING; Labeling	SUPPL	5	AP	2014-04-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-03-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-02-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-03-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-03-26	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-03-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	15

TE Codes

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

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77560
            [companyName] => LUPIN PHARMS
            [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":"ZIPRASIDONE HYDROCHLORIDE","submission":"ZIPRASIDONE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZIPRASIDONE HYDROCHLORIDE","submission":"ZIPRASIDONE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZIPRASIDONE HYDROCHLORIDE","submission":"ZIPRASIDONE HYDROCHLORIDE","actionType":"EQ 60MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZIPRASIDONE HYDROCHLORIDE","submission":"ZIPRASIDONE HYDROCHLORIDE","actionType":"EQ 80MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)