ANDA 076554

SUN PHARM INDS LTD

FDA Drug Application

Application #076554

Documents

• Letter: 2009-08-14

Application Sponsors

ANDA 076554

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE
002	TABLET;ORAL	EQ 50MG BASE	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE

FDA Submissions

	ORIG	1	AP	2009-08-10
LABELING; Labeling	SUPPL	2	AP	2011-02-18
LABELING; Labeling	SUPPL	3	AP	2012-08-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-11-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-07-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76554
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)