ANDA 074421

PLIVA

FDA Drug Application

Application #074421

Application Sponsors

ANDA 074421

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

CYCLOBENZAPRINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1995-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-05-29
LABELING; Labeling	SUPPL	21	AP	2010-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2013-04-02	UNKNOWN
LABELING; Labeling	SUPPL	33	AP	2013-04-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	32	Null	7
SUPPL	33	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74421
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)