ANDA 090397

BIONPHARMA INC

FDA Drug Application

Application #090397

Application Sponsors

ANDA 090397

BIONPHARMA INC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

0

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

FDA Submissions

ORIG

1

AP

2010-11-22

Submissions Property Types

ORIG

1

Null

7

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90397
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN","strength":"25MG;EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN","actionType":"25MG;EQ 200MG FREE ACID AND POTASSIUM SALT","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)