ANDA 078295

SUN PHARM INDS

FDA Drug Application

Application #078295

Documents

• Letter: 2009-08-14

Application Sponsors

ANDA 078295

SUN PHARM INDS

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE
002	TABLET;ORAL	EQ 50MG BASE	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE
003	TABLET;ORAL	EQ 100MG BASE	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE

FDA Submissions

	ORIG	1	AP	2009-08-10
LABELING; Labeling	SUPPL	7	AP	2015-05-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-05-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-04-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	18	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78295
            [companyName] => SUN PHARM INDS
            [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"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 100MG 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"},{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)