PADDOCK LABS FDA Approval ANDA 211951

ANDA 211951

PADDOCK LABS

FDA Drug Application

Application #211951

Documents

Letter2021-01-07

Application Sponsors

ANDA 211951PADDOCK LABS

Marketing Status

None (Tentative Approval)001

Application Products

001SPRAY, METERED;NASAL4MG/SPRAY0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2020-12-18STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PADDOCK LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211951
            [companyName] => PADDOCK LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"4MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211951Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.