NDA 050694

TELIGENT

FDA Drug Application

Application #050694

Documents

• Review: 1999-03-04

Application Sponsors

NDA 050694

TELIGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 40MG BASE/ML	0	CEFOTAN IN PLASTIC CONTAINER	CEFOTETAN DISODIUM
002	INJECTABLE;INJECTION	EQ 20MG BASE/ML	0	CEFOTAN IN PLASTIC CONTAINER	CEFOTETAN DISODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1993-07-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	1995-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50694
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOTAN IN PLASTIC CONTAINER","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOTAN IN PLASTIC CONTAINER","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 20MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFOTAN IN PLASTIC CONTAINER","submission":"CEFOTETAN DISODIUM","actionType":"EQ 40MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOTAN IN PLASTIC CONTAINER","submission":"CEFOTETAN DISODIUM","actionType":"EQ 20MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)