ANDA 088205

PLIVA

FDA Drug Application

Application #088205

Application Sponsors

ANDA 088205

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

4MG

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-07-07
LABELING; Labeling	SUPPL	11	AP	2001-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-05-06
LABELING; Labeling	SUPPL	16	AP	2002-09-05

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88205
            [companyName] => PLIVA
            [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
        )

)