NDA 213026

SAREPTA THERAPS INC

FDA Drug Application

Application #213026

Documents

• Label: 2021-02-26
• Letter: 2021-03-01
• Review: 2021-03-18

Application Sponsors

NDA 213026

SAREPTA THERAPS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

100 mg/2 mL/VIAL

2

AMONDYS 45

CASIMERSEN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-02-25

PRIORITY

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

SAREPTA THERAPS INC

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(
    [0] => Array
        (
            [ApplNo] => 213026
            [companyName] => SAREPTA THERAPS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMONDYS 45","activeIngredients":"CASIMERSEN","strength":"100 mg\/2 mL\/VIAL","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/25\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213026lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213026Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-25
        )

)