ANDA 075750

PLIVA

FDA Drug Application

Application #075750

Documents

• Letter: 2004-06-02

Application Sponsors

ANDA 075750

PLIVA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 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	2001-06-08
LABELING; Labeling	SUPPL	2	AP	2002-08-02

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75750
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXAZOSIN MESYLATE","submission":"DOXAZOSIN MESYLATE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)