ANDA 208991

BRECKENRIDGE

FDA Drug Application

Application #208991

Application Sponsors

ANDA 208991

BRECKENRIDGE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	10MG	0	PIROXICAM	PIROXICAM
002	CAPSULE;ORAL	20MG	0	PIROXICAM	PIROXICAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-02-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208991
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-21
        )

)