ANDA 077797

PRINSTON INC

FDA Drug Application

Application #077797

Application Sponsors

ANDA 077797

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-02-28
LABELING; Labeling	SUPPL	2	AP	2008-08-07
LABELING; Labeling	SUPPL	4	AP	2009-01-06
LABELING; Labeling	SUPPL	10	AP	2013-04-11	STANDARD

Submissions Property Types

SUPPL

10

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77797
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)