NDA 213224

SUN PHARM

FDA Drug Application

Application #213224

Documents

• Label: 2020-01-29
• Letter: 2020-01-29
• Review: 2020-06-01

Application Sponsors

NDA 213224

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)

1

BYNFEZIA PEN

OCTREOTIDE ACETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213224
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"BYNFEZIA PEN","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 2.5MG BASE\/ML (EQ 2.5MG BASE\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/28\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213224s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/28\/2020","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\\\/2020\\\/213224s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213224Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213224Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-01-28
        )

)