ANDA 202539

BIONPHARMA INC

FDA Drug Application

Application #202539

Application Sponsors

ANDA 202539

BIONPHARMA INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	1MCG	0	PARICALCITOL	PARICALCITOL
002	CAPSULE;ORAL	2MCG	0	PARICALCITOL	PARICALCITOL
003	CAPSULE;ORAL	4MCG	0	PARICALCITOL	PARICALCITOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-03-27

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202539
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"2MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"4MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/30\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-30
        )

)