ANDA 040268

JUBILANT CADISTA

FDA Drug Application

Application #040268

Documents

• Review: 1998-02-27

Application Sponsors

ANDA 040268

JUBILANT CADISTA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	PROCOMP	PROCHLORPERAZINE MALEATE
002	TABLET;ORAL	EQ 10MG BASE	0	PROCOMP	PROCHLORPERAZINE MALEATE

FDA Submissions

	ORIG	1	AP	1998-02-27
LABELING; Labeling	SUPPL	3	AP	2004-04-20
LABELING; Labeling	SUPPL	5	AP	2006-06-07
LABELING; Labeling	SUPPL	9	AP	2008-09-03
LABELING; Labeling	SUPPL	11	AP	2008-12-18
LABELING; Labeling	SUPPL	12	AP	2010-01-14
LABELING; Labeling	SUPPL	13	AP	2009-04-30
LABELING; Labeling	SUPPL	14	AP	2009-07-15
LABELING; Labeling	SUPPL	15	AP	2009-08-18
LABELING; Labeling	SUPPL	16	AP	2010-12-03
LABELING; Labeling	SUPPL	21	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	12	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	21	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40268
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCOMP","activeIngredients":"PROCHLORPERAZINE MALEATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROCOMP","activeIngredients":"PROCHLORPERAZINE MALEATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCOMP","submission":"PROCHLORPERAZINE MALEATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROCOMP","submission":"PROCHLORPERAZINE MALEATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)