Heron Therapeutics, Inc. FDA Approval NDA 211988

NDA 211988

Heron Therapeutics, Inc.

FDA Drug Application

Application #211988

Documents

Letter2021-05-13
Label2021-05-13

Application Sponsors

NDA 211988Heron Therapeutics, Inc.

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SOLUTION;INJECTION60MG/1.8MG0Zynrelefbupivacaine and meloxicam
002SOLUTION; INJECTION200MG/6MG0Zynrelefbupivacaine and meloxicam
003SOLUTION; INJECTION300MG/9MG0Zynrelefbupivacaine and meloxicam
004SOLUTION; INJECTION400MG/12MG0Zynrelefbupivacaine and meloxicam

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2021-05-12PRIORITY

Submissions Property Types

ORIG1Null2

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD
004PrescriptionTBD

CDER Filings

Heron Therapeutics, Inc.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211988
            [companyName] => Heron Therapeutics, Inc.
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYNRELEF KIT","activeIngredients":"BUPIVACAINE; MELOXICAM","strength":"60MG; 1.8MG","dosageForm":"SOLUTION, EXTENDED RELEASE;INSTILLATION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ZYNRELEF KIT","activeIngredients":"BUPIVACAINE; MELOXICAM","strength":"200MG; 6MG","dosageForm":"SOLUTION, EXTENDED RELEASE;INSTILLATION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ZYNRELEF KIT","activeIngredients":"BUPIVACAINE; MELOXICAM","strength":"300MG; 9MG","dosageForm":"SOLUTION, EXTENDED RELEASE;INSTILLATION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ZYNRELEF KIT","activeIngredients":"BUPIVACAINE; MELOXICAM","strength":"400MG; 12MG","dosageForm":"SOLUTION, EXTENDED RELEASE;INSTILLATION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/12\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211988s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211988s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211988Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-12
        )

)

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