ANDA 200900

BIONPHARMA INC

FDA Drug Application

Application #200900

Application Sponsors

ANDA 200900

BIONPHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	100MG	0	PROGESTERONE	PROGESTERONE
002	CAPSULE;ORAL	200MG	0	PROGESTERONE	PROGESTERONE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-08-16

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200900
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-08-16
        )

)