ANDA 212469

PADAGIS ISRAEL

FDA Drug Application

Application #212469

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 212469

PADAGIS ISRAEL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SPRAY;NASAL	2.5MG/SPRAY	0	ZOLMITRIPTAN	ZOLMITRIPTAN
002	SPRAY;NASAL	5MG/SPRAY	0	ZOLMITRIPTAN	ZOLMITRIPTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-09-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PADAGIS ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212469
            [companyName] => PADAGIS ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-30
        )

)