NDA 215935

CALLIDITAS THERAPEUTICS AB

FDA Drug Application

Application #215935

Documents

• Label: 2021-12-20
• Letter: 2021-12-21
• Review: 2022-10-20

Application Sponsors

NDA 215935

CALLIDITAS THERAPEUTICS AB

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED RELEASE;ORAL

4MG

2

TARPEYO

BUDESONIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-12-15

PRIORITY

Submissions Property Types

ORIG

1

Orphan

5

TE Codes

001

Prescription

TBD

CDER Filings

CALLIDITAS THERAPEUTICS AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215935
            [companyName] => CALLIDITAS THERAPEUTICS AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARPEYO","activeIngredients":"BUDESONIDE","strength":"4MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215935s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215935s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215935Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-15
        )

)