ANDA 208964

LUPIN

FDA Drug Application

Application #208964

Application Sponsors

ANDA 208964

LUPIN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

300MG/5ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-02-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AN

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208964
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/06\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-06
        )

)