NDA 213426

ESTEVE PHARMACEUTICALS SA

FDA Drug Application

Application #213426

Documents

• Label: 2021-10-18
• Medication Guide: 2021-10-18
• Letter: 2021-10-19
• Review: 2022-07-15
• Letter: 2023-01-09
• Label: 2023-01-10

Application Sponsors

NDA 213426

ESTEVE PHARMACEUTICALS SA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

56MG;44MG

0

SEGLENTIS

CELECOXIB;TRAMADOL HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2021-10-15

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

ESTEVE PHARMACEUTICALS SA

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(
    [0] => Array
        (
            [ApplNo] => 213426
            [companyName] => ESTEVE PHARMACEUTICALS SA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/213426s000lbl.pdf#page=66"]
            [products] => [{"drugName":"SEGLENTIS","activeIngredients":"CELECOXIB;TRAMADOL HYDROCHLORIDE","strength":"56MG;44MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213426s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213426s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-15
        )

)