ANDA 202053

WATSON LABS INC

FDA Drug Application

Application #202053

Documents

• Letter: 2014-09-16
• Label: 2014-09-23

Application Sponsors

ANDA 202053

WATSON LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE

0

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2014-09-11

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

INDOCO

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            [ApplNo] => 202053
            [companyName] => INDOCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE","strength":"EQ 2% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/11\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202053Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202053Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202053Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2014-09-11
        )

)