ANDA 077921

ZYDUS PHARMS USA

FDA Drug Application

Application #077921

Documents

• Letter: 2009-05-18

Application Sponsors

ANDA 077921

ZYDUS PHARMS USA

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	2	AP	2007-11-20
LABELING; Labeling	SUPPL	7	AP	2008-09-23
LABELING; Labeling	SUPPL	9	AP	2014-09-03
LABELING; Labeling	SUPPL	12	AP	2010-08-27
LABELING; Labeling	SUPPL	13	AP	2010-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-04-20
LABELING; Labeling	SUPPL	15	AP	2010-10-26
LABELING; Labeling	SUPPL	17	AP	2015-09-10
LABELING; Labeling	SUPPL	18	AP	2015-09-10
LABELING; Labeling	SUPPL	21	AP	2015-09-10	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-08-15	STANDARD
LABELING; Labeling	SUPPL	30	AP	2016-08-15	STANDARD
LABELING; Labeling	SUPPL	34	AP	2023-01-05	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	12	Null	8
SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	21	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	34	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77921
            [companyName] => ZYDUS PHARMS USA
            [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
        )

)