NDA 007959

TELIGENT

FDA Drug Application

Application #007959

Documents

• Letter: 2002-04-24
• Letter: 2002-04-24

Application Sponsors

NDA 007959

TELIGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	TENSILON	EDROPHONIUM CHLORIDE
002	INJECTABLE;INJECTION	10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	TENSILON PRESERVATIVE FREE	EDROPHONIUM CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1951-05-03	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1983-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-03-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-01-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-08-09	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2002-04-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-10-01	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2003-02-26	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 7959
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENSILON","activeIngredients":"EDROPHONIUM CHLORIDE","strength":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TENSILON PRESERVATIVE FREE","activeIngredients":"EDROPHONIUM CHLORIDE","strength":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TENSILON","submission":"EDROPHONIUM CHLORIDE","actionType":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TENSILON PRESERVATIVE FREE","submission":"EDROPHONIUM CHLORIDE","actionType":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)