NDA 210895

DAIICHI SANKYO INC

FDA Drug Application

Application #210895

Documents

• Letter: 2019-09-03
• Label: 2019-04-04
• Review: 2019-09-03
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2020-05-13
• Label: 2020-05-13
• Pediatric Medical Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01

Application Sponsors

NDA 210895

DAIICHI SANKYO INC

Marketing Status

• Prescription: 001

Application Products

001

BAR, CHEWABLE;ORAL

3.75GM

1

WELCHOL

COLESEVELAM HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2019-04-03

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

DAIICHI SANKYO INC

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            [companyName] => DAIICHI SANKYO INC
            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022362s027,021776s047,210895s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210895s000lbl.pdf\"}]","notes":""}]
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            [supplements] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022362s027,021776s047,210895s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/022362Orig1s027,021176Orig1s047,210895Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-05-12
        )

)