ANDA 202719

SANDOZ INC

FDA Drug Application

Application #202719

Application Sponsors

ANDA 202719

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;TOPICAL

0.03%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-04-19
LABELING; Labeling	SUPPL	2	AP	2022-11-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AT

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202719
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-19
        )

)