ANDA 040578

TWI PHARMS

FDA Drug Application

Application #040578

Documents

• Letter: 2006-04-20

Application Sponsors

ANDA 040578

TWI PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

BENZPHETAMINE HYDROCHLORIDE

BENZPHETAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-04-17
LABELING; Labeling	SUPPL	9	AP	2009-05-21
LABELING; Labeling	SUPPL	10	AP	2009-08-31
LABELING; Labeling	SUPPL	11	AP	2010-05-10

Submissions Property Types

SUPPL

10

Null

7

TE Codes

001

Prescription

AA

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40578
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZPHETAMINE HYDROCHLORIDE","activeIngredients":"BENZPHETAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZPHETAMINE HYDROCHLORIDE","submission":"BENZPHETAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)