ANDA 205348

CROSSMEDIKA SA

FDA Drug Application

Application #205348

Application Sponsors

ANDA 205348

CROSSMEDIKA SA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 400MG BASE

0

MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-01-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-02-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CROSSMEDIKA SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205348
            [companyName] => CROSSMEDIKA SA
            [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":"01\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/07\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/07\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/07\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-07
        )

)