ANDA 086263

CHARTWELL RX

FDA Drug Application

Application #086263

Application Sponsors

ANDA 086263

CHARTWELL RX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

DUVOID

BETHANECHOL CHLORIDE

FDA Submissions

	ORIG	1	AP	1978-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-09-29
LABELING; Labeling	SUPPL	13	AP	1988-11-15
LABELING; Labeling	SUPPL	14	AP	1989-12-28
LABELING; Labeling	SUPPL	15	AP	1996-07-11
LABELING; Labeling	SUPPL	22	AP	2004-06-28

Submissions Property Types

SUPPL

11

Null

0

TE Codes

001

Prescription

AA

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86263
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUVOID","activeIngredients":"BETHANECHOL CHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DUVOID","submission":"BETHANECHOL CHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)