ANDA 207080

DR REDDYS LABS SA

FDA Drug Application

Application #207080

Application Sponsors

ANDA 207080

DR REDDYS LABS SA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

300MG/5ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-02-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AN

CDER Filings

DR REDDYS LABS SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207080
            [companyName] => DR REDDYS LABS SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/20\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-20
        )

)