NDA 211939

ALVOGEN

FDA Drug Application

Application #211939

Documents

• Label: 2019-10-07
• Medication Guide: 2019-10-07
• Letter: 2019-10-07
• Review: 2020-02-26

Application Sponsors

NDA 211939

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

0.62MG/2.48ML (0.25MG/ML)

0

BONSITY

TERIPARATIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-10-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211939
            [companyName] => ALVOGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/211939s000lbl.pdf#page=25"]
            [products] => [{"drugName":"BONSITY","activeIngredients":"TERIPARATIDE","strength":"0.62MG\/2.48ML (0.25MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211939s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211939s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211939Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211939Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-10-04
        )

)