ANDA 213465

PERRIGO UK FINCO

FDA Drug Application

Application #213465

Application Sponsors

ANDA 213465

PERRIGO UK FINCO

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SPRAY;NASAL	20MG/SPRAY	0	SUMATRIPTAN	SUMATRIPTAN
002	SPRAY;NASAL	5MG/SPRAY	0	SUMATRIPTAN	SUMATRIPTAN SUCCINATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213465
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN","activeIngredients":"SUMATRIPTAN","strength":"20MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-21
        )

)