ANDA 090604

SANDOZ INC

FDA Drug Application

Application #090604

Application Sponsors

ANDA 090604

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE;EQ 0.5% BASE

0

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

FDA Submissions

	ORIG	1	AP	2009-11-18
LABELING; Labeling	SUPPL	5	AP	2021-03-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AT

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90604
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","strength":"EQ 2% BASE;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","submission":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","actionType":"EQ 2% BASE;EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)