ANDA 078319

ANTARES PHARMA INC

FDA Drug Application

Application #078319

Application Sponsors

ANDA 078319

ANTARES PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE
002	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	0	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE

FDA Submissions

ORIG

1

AP

2015-12-10

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANTARES PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78319
            [companyName] => ANTARES PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 4MG BASE\/0.5ML (EQ 8MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 6MG BASE\/0.5ML (EQ 12MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 4MG BASE\/0.5ML (EQ 8MG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 6MG BASE\/0.5ML (EQ 12MG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)