ANDA 075609

NESHER PHARMS

FDA Drug Application

Application #075609

Documents

• Letter: 2000-10-18
• Label: 2004-06-02
• Review: 2003-07-30

Application Sponsors

ANDA 075609

NESHER PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE
002	TABLET;ORAL	EQ 2MG BASE	0	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE
003	TABLET;ORAL	EQ 4MG BASE	0	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE
004	TABLET;ORAL	EQ 8MG BASE	0	DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE

FDA Submissions

	ORIG	1	AP	2000-10-18
LABELING; Labeling	SUPPL	2	AP	2002-09-10

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75609
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/18\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/75609_Doxazosin%20Mesylate_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-10-18
        )

)