ANDA 091552

SUN PHARM INDS LTD

FDA Drug Application

Application #091552

Application Sponsors

ANDA 091552

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 2.5MG BASE

0

NARATRIPTAN

NARATRIPTAN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-02-14
LABELING; Labeling	SUPPL	2	AP	2015-09-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91552
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NARATRIPTAN","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NARATRIPTAN","submission":"NARATRIPTAN HYDROCHLORIDE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)