ANDA 077565

DR REDDYS LABS INC

FDA Drug Application

Application #077565

Documents

• Letter: 2011-04-21

Application Sponsors

ANDA 077565

DR REDDYS LABS INC

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	3	AP	2013-07-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-09-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-04-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-11-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-11-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-11-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-11-02	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	18	Null	7

TE Codes

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

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77565
            [companyName] => DR REDDYS LABS INC
            [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
        )

)