NDA 211039

BAUSCH

FDA Drug Application

Application #211039

Documents

• Label: 2020-03-09
• Letter: 2020-05-11
• Review: 2020-10-29

Application Sponsors

NDA 211039

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.4%;0.3%

1

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2020-03-09

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

BAUSCH

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(
    [0] => Array
        (
            [ApplNo] => 211039
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE","activeIngredients":"BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM","strength":"0.4%;0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/09\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211039Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211039Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211039Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-09
        )

)