ANDA 090449

APOTEX INC

FDA Drug Application

Application #090449

Documents

• Label: 2015-07-23
• Letter: 2015-07-22

Application Sponsors

ANDA 090449

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.03%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

	ORIG	1	AP	2015-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2018-11-20	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2022-12-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	8	Null	7

TE Codes

001

Prescription

AT

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90449
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/20\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/090449Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BIMATOPROST","submission":"BIMATOPROST","actionType":"0.03%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-07-20
        )

)