ANDA 077918

YUNG SHIN PHARM

FDA Drug Application

Application #077918

Application Sponsors

ANDA 077918

YUNG SHIN PHARM

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	2006-12-07
LABELING; Labeling	SUPPL	2	AP	2009-09-24
LABELING; Labeling	SUPPL	3	AP	2010-09-10
LABELING; Labeling	SUPPL	4	AP	2013-06-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-10-22	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77918
            [companyName] => YUNG SHIN PHARM
            [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
        )

)