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FDA NDA · NDA022496

EXPAREL

bupivacaine

Sponsor: PACIRA PHARMS INC

APPLICATION
NDA022496
TYPE
NDA
ORIGINAL APPROVAL
2011-10-28
LATEST ACTION
2023-11-28
ROUTE
INFILTRATION, INJECTION
DOSAGE FORM
INJECTABLE, LIPOSOMAL
MARKETING STATUS
Prescription

Products

EXPAREL · ReferencePrescription
BUPIVACAINE 266MG/20ML (13.3MG/ML) · INJECTABLE, LIPOSOMAL · INJECTION
EXPAREL · ReferencePrescription
BUPIVACAINE 133MG/10ML (13.3MG/ML) · INJECTABLE, LIPOSOMAL · INJECTION

Approval history

2023-11-28Labeling · Supplement 51 · standard — Label ↗AP
2023-11-09Efficacy · Supplement 44 · standard — Label ↗AP
2021-04-02Manufacturing (CMC) · Supplement 37 — Review ↗AP
2021-03-22Efficacy · Supplement 35 · standard — Label ↗AP
2021-01-06Labeling · Supplement 36 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 30 · standard — Label ↗AP
2018-04-06Efficacy · Supplement 9 · standard — Label ↗AP
2017-03-08Labeling · Supplement 23 · standardAP
2016-06-10Manufacturing (CMC) · Supplement 20 · standardAP
2016-04-15Manufacturing (CMC) · Supplement 18 · standardAP
2016-04-05Manufacturing (CMC) · Supplement 17 · standardAP
2015-12-14Labeling · Supplement 19 · standard — Label ↗AP
2015-10-08Manufacturing (CMC) · Supplement 16 · standardAP
2015-09-11Manufacturing (CMC) · Supplement 15 · standardAP
2015-07-27Manufacturing (CMC) · Supplement 14 · standardAP
2015-05-27Manufacturing (CMC) · Supplement 12 · standardAP
2014-12-15Manufacturing (CMC) · Supplement 10 · standardAP
2014-12-05Labeling · Supplement 5 · standard — Letter ↗AP
2014-08-13Manufacturing (CMC) · Supplement 8 · standardAP
2014-06-05Manufacturing (CMC) · Supplement 7 · standardAP
2014-03-28Manufacturing (CMC) · Supplement 6 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 4 · standardAP
2011-10-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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