WATSON LABS INC FDA Approval ANDA 202054

Application #202054

Documents

Letter

2014-09-05

Application Sponsors

ANDA 202054

WATSON LABS INC

Marketing Status

Discontinued

001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE;EQ 0.5% BASE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-09-03
LABELING; Labeling	SUPPL	2	AP	2021-02-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

CDER Filings

INDOCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202054
            [companyName] => INDOCO
            [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":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202054Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-09-03
        )

)