ANDA 208818

LUPIN LTD

FDA Drug Application

Application #208818

Application Sponsors

ANDA 208818

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 75MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE
002	TABLET;ORAL	EQ 150MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208818
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/26\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-26
        )

)