ANDA 076740

BIONPHARMA INC

FDA Drug Application

Application #076740

Documents

• Review: 2012-01-27

Application Sponsors

ANDA 076740

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

30MG

0

NIMODIPINE

NIMODIPINE

FDA Submissions

	ORIG	1	AP	2008-01-17
LABELING; Labeling	SUPPL	4	AP	2012-02-28

Submissions Property Types

SUPPL

4

Null

15

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76740
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIMODIPINE","activeIngredients":"NIMODIPINE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NIMODIPINE","submission":"NIMODIPINE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)