ANDA 208719

ZYDUS PHARMS

FDA Drug Application

Application #208719

Documents

• Letter: 2017-07-11

Application Sponsors

ANDA 208719

ZYDUS PHARMS

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

UNKNOWN;

ORIG

1

AP

2017-07-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208719
            [companyName] => ZYDUS PHARMS
            [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":"07\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208719Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-07
        )

)