NDA 211988

Heron Therapeutics, Inc.

FDA Drug Application

Application #211988

Documents

• Letter: 2021-05-13
• Label: 2021-05-13
• Letter: 2021-12-09
• Label: 2021-12-10
• Review: 2022-04-05
• Review: 2022-06-28

Application Sponsors

NDA 211988

Heron Therapeutics, Inc.

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;INJECTION	60MG/1.8MG	0	Zynrelef	bupivacaine and meloxicam
002	SOLUTION; INJECTION	200MG/6MG	0	Zynrelef	bupivacaine and meloxicam
003	SOLUTION; INJECTION	300MG/9MG	0	Zynrelef	bupivacaine and meloxicam
004	SOLUTION; INJECTION	400MG/12MG	0	Zynrelef	bupivacaine and meloxicam

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2021-05-12	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2021-12-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	5	Null	7
SUPPL	10	Null	6

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD
004	Prescription	TBD

CDER Filings

Heron Therapeutics, Inc.

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(
    [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
        )

)