ANDA 211951

PADDOCK LABS

FDA Drug Application

Application #211951

Documents

• Letter: 2021-01-07

Application Sponsors

ANDA 211951

PADDOCK LABS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SPRAY, METERED;NASAL

4MG/SPRAY

0

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

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
        )

)