ANDA 200160

TORRENT

FDA Drug Application

Application #200160

Application Sponsors

ANDA 200160

TORRENT

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 400MG BASE

0

MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-04-03
LABELING; Labeling	SUPPL	2	AP	2020-11-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-11-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-11-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200160
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-04-03
        )

)