ANDA 088212

CHARTWELL RX

FDA Drug Application

Application #088212

Application Sponsors

ANDA 088212

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

4MG

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-10-10
LABELING; Labeling	SUPPL	8	AP	1989-11-20
LABELING; Labeling	SUPPL	9	AP	1991-03-04
LABELING; Labeling	SUPPL	12	AP	1997-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-10-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	14	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88212
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYPROHEPTADINE HYDROCHLORIDE","submission":"CYPROHEPTADINE HYDROCHLORIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)