ANDA 085882

CHARTWELL RX

FDA Drug Application

Application #085882

Application Sponsors

ANDA 085882

CHARTWELL RX

Marketing Status

• Prescription: 003

Application Products

003

TABLET;ORAL

50MG

0

DUVOID

BETHANECHOL CHLORIDE

FDA Submissions

	ORIG	1	AP	1978-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-03-12
LABELING; Labeling	SUPPL	14	AP	1990-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-11-17
LABELING; Labeling	SUPPL	25	AP	2005-01-28

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	18	Null	0

TE Codes

003

Prescription

AA

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85882
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUVOID","activeIngredients":"BETHANECHOL CHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DUVOID","submission":"BETHANECHOL CHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)