ANDA 091174

BIONPHARMA INC

FDA Drug Application

Application #091174

Application Sponsors

ANDA 091174

BIONPHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	0.25MCG	0	CALCITRIOL	CALCITRIOL
002	CAPSULE;ORAL	0.5MCG	0	CALCITRIOL	CALCITRIOL

FDA Submissions

ORIG

1

AP

2013-05-24

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91174
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.25MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.25MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)