ANDA 074921

MAYNE PHARMA

FDA Drug Application

Application #074921

Documents

• Medication Guide: 2013-07-01

Application Sponsors

ANDA 074921

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	1MG	0	ESTAZOLAM	ESTAZOLAM
002	TABLET;ORAL	2MG	0	ESTAZOLAM	ESTAZOLAM

FDA Submissions

	ORIG	1	AP	1997-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-08
LABELING; Labeling	SUPPL	11	AP	2009-01-08
LABELING; Labeling	SUPPL	12	AP	2008-02-20
LABELING; Labeling	SUPPL	15	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-02-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-02-05	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	15	Null	7
SUPPL	16	Null	15
SUPPL	19	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74921
            [companyName] => MAYNE PHARMA
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM359235.pdf"]
            [products] => [{"drugName":"ESTAZOLAM","activeIngredients":"ESTAZOLAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTAZOLAM","activeIngredients":"ESTAZOLAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTAZOLAM","submission":"ESTAZOLAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTAZOLAM","submission":"ESTAZOLAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)