NDA 208251

LABORATORIOS SALVAT

FDA Drug Application

Application #208251

Documents

• Letter: 2016-05-02
• Label: 2016-05-03
• Review: 2017-10-20
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 208251

LABORATORIOS SALVAT

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OTIC

EQ 0.3% BASE;0.025%

1

OTOVEL

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

LABORATORIOS SALVAT

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(
    [0] => Array
        (
            [ApplNo] => 208251
            [companyName] => LABORATORIOS SALVAT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OTOVEL","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE","strength":"EQ 0.3% BASE;0.025%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208251orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208251orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208251Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208251Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-04-29
        )

)