ANDA 065200

CHARTWELL RX

FDA Drug Application

Application #065200

Documents

• Review: 2008-07-31

Application Sponsors

ANDA 065200

CHARTWELL RX

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

125MG/5ML

0

GRISEOFULVIN

GRISEOFULVIN, MICROSIZE

FDA Submissions

	ORIG	1	AP	2005-03-02
LABELING; Labeling	SUPPL	4	AP	2007-12-31

TE Codes

001

Prescription

AB

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65200
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRISEOFULVIN","activeIngredients":"GRISEOFULVIN, MICROSIZE","strength":"125MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRISEOFULVIN","submission":"GRISEOFULVIN, MICROSIZE","actionType":"125MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)