ANDA 074929

ECI PHARMS LLC

FDA Drug Application

Application #074929

Documents

• Letter: 1998-01-30
• Label: 1998-01-30
• Review: 1998-01-30

Application Sponsors

ANDA 074929

ECI PHARMS LLC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

300MG

0

ETODOLAC

ETODOLAC

FDA Submissions

ORIG

1

AP

1998-01-30

CDER Filings

BIOPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74929
            [companyName] => BIOPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/74929ap_appltr_prntlbl_chemr.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ETODOLAC","submission":"ETODOLAC","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-01-30
        )

)