ANDA 078751

ANI PHARMS INC

FDA Drug Application

Application #078751

Documents

• Letter: 2010-07-09

Application Sponsors

ANDA 078751

ANI PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE
002	TABLET;ORAL	EQ 2.5MG BASE	0	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-07-07
LABELING; Labeling	SUPPL	2	AP	2012-04-24
LABELING; Labeling	SUPPL	5	AP	2015-07-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	15

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78751
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NARATRIPTAN","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NARATRIPTAN","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NARATRIPTAN","submission":"NARATRIPTAN HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NARATRIPTAN","submission":"NARATRIPTAN HYDROCHLORIDE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)