ANDA 074559

MYLAN TECHNOLOGIES

FDA Drug Application

Application #074559

Application Sponsors

ANDA 074559

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	0.6MG/HR	0	NITROGLYCERIN	NITROGLYCERIN
002	FILM, EXTENDED RELEASE;TRANSDERMAL	0.4MG/HR	0	NITROGLYCERIN	NITROGLYCERIN
003	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/HR	0	NITROGLYCERIN	NITROGLYCERIN
004	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/HR	0	NITROGLYCERIN	NITROGLYCERIN

FDA Submissions

	ORIG	1	AP	1996-08-30
LABELING; Labeling	SUPPL	2	AP	1998-12-22
LABELING; Labeling	SUPPL	3	AP	1999-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-07-15

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2
004	Prescription	AB2

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74559
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.6MG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.4MG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.2MG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.1MG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.6MG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.4MG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.2MG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.1MG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)