ANDA 077533

INVAGEN PHARMS

FDA Drug Application

Application #077533

Documents

• Letter: 2007-07-05

Application Sponsors

ANDA 077533

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 250MG BASE

0

TERBINAFINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-07-02
LABELING; Labeling	SUPPL	3	AP	2011-09-20
LABELING; Labeling	SUPPL	5	AP	2012-07-12	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-01-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-01-10	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77533
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERBINAFINE HYDROCHLORIDE","activeIngredients":"TERBINAFINE HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERBINAFINE HYDROCHLORIDE","submission":"TERBINAFINE HYDROCHLORIDE","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)