NDA 022445

HERON THERAPS INC

FDA Drug Application

Application #022445

Documents

• Label: 2016-08-09
• Letter: 2016-08-09
• Medication Guide: 2016-10-12
• Review: 2018-09-18

Application Sponsors

NDA 022445

HERON THERAPS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTION, EXTENDED RELEASE;SUBCUTANEOUS

10MG/0.4ML (10MG/0.4ML)

1

SUSTOL

GRANISETRON

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-08-09

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

HERON THERAPS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22445
            [companyName] => HERON THERAPS INC
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM524796.pdf"]
            [products] => [{"drugName":"SUSTOL","activeIngredients":"GRANISETRON","strength":"10MG\/0.4ML (10MG\/0.4ML)","dosageForm":"INJECTION, EXTENDED RELEASE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/09\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022445s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SUSTOL","submission":"GRANISETRON","actionType":"10MG\/0.4ML (10MG\/0.4ML)","submissionClassification":"INJECTION, EXTENDED RELEASE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-08-09
        )

)