ANDA 201894

APOTEX INC

FDA Drug Application

Application #201894

Application Sponsors

ANDA 201894

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;TOPICAL

0.03%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2018-12-10	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2022-08-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-08-03	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AT

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201894
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/10\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-12-10
        )

)