ANDA 060569

CHARTWELL RX

FDA Drug Application

Application #060569

Application Sponsors

ANDA 060569

CHARTWELL RX

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	500MG	0	FULVICIN-U/F	GRISEOFULVIN, MICROCRYSTALLINE
002	TABLET;ORAL	250MG	0	FULVICIN-U/F	GRISEOFULVIN, MICROCRYSTALLINE

FDA Submissions

	ORIG	1	AP	1971-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-01-26

Submissions Property Types

SUPPL

7

Null

0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60569
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVICIN-U\/F","activeIngredients":"GRISEOFULVIN, MICROCRYSTALLINE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FULVICIN-U\/F","activeIngredients":"GRISEOFULVIN, MICROCRYSTALLINE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FULVICIN-U\/F","submission":"GRISEOFULVIN, MICROCRYSTALLINE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FULVICIN-U\/F","submission":"GRISEOFULVIN, MICROCRYSTALLINE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)