ANDA 209487

LUPIN LTD

FDA Drug Application

Application #209487

Documents

• Letter: 2020-08-21

Application Sponsors

ANDA 209487

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	5MG	0	MELOXICAM	MELOXICAM
002	CAPSULE;ORAL	10MG	0	MELOXICAM	MELOXICAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209487
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MELOXICAM","activeIngredients":"MELOXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-01
        )

)