ANDA 208682

MSN

FDA Drug Application

Application #208682

Application Sponsors

ANDA 208682

MSN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 400MG BASE

0

MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-06-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-06-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-06-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MSN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208682
            [companyName] => MSN
            [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":"09\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/03\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/03\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-03
        )

)