NDA 013055

TELIGENT

FDA Drug Application

Application #013055

Documents

• Letter: 2008-02-14
• Label: 2008-02-14

Application Sponsors

NDA 013055

TELIGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

30MG/ML

1

NORFLEX

ORPHENADRINE CITRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1960-10-02	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1975-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1978-03-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1978-11-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-08-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-09-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-09-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-11-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-06-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-06-04	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2008-02-11	STANDARD

Submissions Property Types

SUPPL	8	Null	14
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13055
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORFLEX","activeIngredients":"ORPHENADRINE CITRATE","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/11\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/013055s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NORFLEX","submission":"ORPHENADRINE CITRATE","actionType":"30MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-02-11
        )

)