ANDA 211398

NOVITIUM PHARMA

FDA Drug Application

Application #211398

Application Sponsors

ANDA 211398

NOVITIUM PHARMA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	CAPSULE;ORAL	5MG	0	MELOXICAM	MELOXICAM
002	CAPSULE;ORAL	10MG	0	MELOXICAM	MELOXICAM

FDA Submissions

UNKNOWN;	ORIG	1	TA	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-10-11	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211398
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-15
        )

)