ANDA 077931

DR REDDYS LABS INC

FDA Drug Application

Application #077931

Application Sponsors

ANDA 077931

DR REDDYS LABS INC

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	2006-07-25
LABELING; Labeling	SUPPL	2	AP	2008-08-22
LABELING; Labeling	SUPPL	3	AP	2016-10-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-10-17	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77931
            [companyName] => DR REDDYS LABS INC
            [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
        )

)