NDA 209229

US WORLDMEDS LLC

FDA Drug Application

Application #209229

Documents

• Label: 2018-05-16
• Letter: 2018-05-16
• Review: 2018-06-28

Application Sponsors

NDA 209229

US WORLDMEDS LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 0.18MG BASE

1

LUCEMYRA

LOFEXIDINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2018-05-16

PRIORITY

Submissions Property Types

ORIG

1

Null

40

CDER Filings

USWM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209229
            [companyName] => USWM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUCEMYRA","activeIngredients":"LOFEXIDINE HYDROCHLORIDE","strength":"EQ 0.18MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/16\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209229s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209229s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209229Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209229Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-05-16
        )

)