NDA 208085

ECI PHARMS LLC

FDA Drug Application

Application #208085

Documents

• Label: 2018-04-26
• Letter: 2018-04-27
• Label: 2018-11-01
• Letter: 2018-11-06
• Review: 2018-12-14

Application Sponsors

NDA 208085

ECI PHARMS LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

400MG;5MG

1

XTRELUS

GUAIFENESIN; HYDROCODONE BITARTRATE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination

ORIG

1

AP

2018-04-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ECI PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208085
            [companyName] => ECI PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XTRELUS","activeIngredients":"GUAIFENESIN; HYDROCODONE BITARTRATE","strength":"400MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/31\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208085s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208085s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208085s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208085s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208085Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208085Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/31\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208085s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208085Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-10-31
        )

)