ANDA 091449

SANDOZ INC

FDA Drug Application

Application #091449

Application Sponsors

ANDA 091449

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.005%

0

LATANOPROST

LATANOPROST

FDA Submissions

	ORIG	1	AP	2011-03-22
LABELING; Labeling	SUPPL	6	AP	2020-02-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-08-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AT

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91449
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LATANOPROST","submission":"LATANOPROST","actionType":"0.005%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)