ANDA 077927

UNICHEM

FDA Drug Application

Application #077927

Application Sponsors

ANDA 077927

UNICHEM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	7.5MG	0	MELOXICAM	MELOXICAM
002	TABLET;ORAL	15MG	0	MELOXICAM	MELOXICAM

FDA Submissions

	ORIG	1	AP	2006-12-20
LABELING; Labeling	SUPPL	2	AP	2009-01-21
LABELING; Labeling	SUPPL	9	AP	2011-03-03
LABELING; Labeling	SUPPL	11	AP	2011-03-31
LABELING; Labeling	SUPPL	14	AP	2013-06-13	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-10-22	STANDARD

Submissions Property Types

SUPPL	14	Null	15
SUPPL	17	Null	15
SUPPL	26	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UNICHEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77927
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MELOXICAM","submission":"MELOXICAM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MELOXICAM","submission":"MELOXICAM","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)