ANDA 204439

APOTEX

FDA Drug Application

Application #204439

Application Sponsors

ANDA 204439

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

50MG/VIAL

0

TIGECYCLINE

TIGECYCLINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-21
LABELING; Labeling	SUPPL	3	AP	2021-02-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AP

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204439
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)