ANDA 209582

ZYDUS PHARMS

FDA Drug Application

Application #209582

Application Sponsors

ANDA 209582

ZYDUS PHARMS

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 50MG BASE	0	DOXYCYCLINE	DOXYCYCLINE
002	TABLET;ORAL	EQ 75MG BASE	0	DOXYCYCLINE	DOXYCYCLINE
003	TABLET;ORAL	EQ 100MG BASE	0	DOXYCYCLINE	DOXYCYCLINE
004	TABLET;ORAL	EQ 150MG BASE	0	DOXYCYCLINE	DOXYCYCLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209582
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-28
        )

)