ANDA 077944

LUPIN PHARMS

FDA Drug Application

Application #077944

Documents

• Letter: 2006-07-21

Application Sponsors

ANDA 077944

LUPIN PHARMS

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	2006-07-19
LABELING; Labeling	SUPPL	3	AP	2008-10-27
LABELING; Labeling	SUPPL	8	AP	2010-09-30
LABELING; Labeling	SUPPL	9	AP	2011-01-28
LABELING; Labeling	SUPPL	12	AP	2015-07-01	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-10-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-10-04	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-01-07	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	19	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77944
            [companyName] => LUPIN PHARMS
            [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
        )

)