NDA 021141

DAIICHI SANKYO

FDA Drug Application

Application #021141

Documents

• Letter: 2000-05-26
• Label: 2000-05-26
• Review: 2000-05-26

Application Sponsors

NDA 021141

DAIICHI SANKYO

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

375MG

0

WELCHOL

COLESEVELAM HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2000-05-26

STANDARD

CDER Filings

DAIICHI SANKYO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21141
            [companyName] => DAIICHI SANKYO
            [docInserts] => ["",""]
            [products] => [{"drugName":"WELCHOL","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"375MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/26\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21176lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"WELCHOL","submission":"COLESEVELAM HYDROCHLORIDE","actionType":"375MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-05-26
        )

)