ANDA 072854

UPSHER SMITH LABS

FDA Drug Application

Application #072854

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 072854

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	1991-11-19
LABELING; Labeling	SUPPL	2	AP	1994-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-02-05
LABELING; Labeling	SUPPL	5	AP	1999-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-08-27
LABELING; Labeling	SUPPL	12	AP	2005-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2006-02-03
LABELING; Labeling	SUPPL	15	AP	2006-02-03
LABELING; Labeling	SUPPL	23	AP	2015-07-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	23	Null	7

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72854
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)