ANDA 086833

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #086833

Application Sponsors

ANDA 086833

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1980-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-11-05
LABELING; Labeling	SUPPL	16	AP	1989-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1989-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-03-03
LABELING; Labeling	SUPPL	20	AP	1989-10-11
LABELING; Labeling	SUPPL	21	AP	1989-12-26
LABELING; Labeling	SUPPL	22	AP	1990-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1990-09-28
LABELING; Labeling	SUPPL	25	AP	1997-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-10-02

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86833
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"2MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYPROHEPTADINE HYDROCHLORIDE","submission":"CYPROHEPTADINE HYDROCHLORIDE","actionType":"2MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)