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FDA NDA · NDA204803

POSIMIR

Sponsor: INNOCOLL

APPLICATION
NDA204803
TYPE
NDA
ORIGINAL APPROVAL
2021-02-01
LATEST ACTION
2022-08-03
ROUTE
INFILTRATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

POSIMIR · ReferenceDiscontinued
BUPIVACAINE 660MG/5ML (132MG/ML) · SOLUTION · INFILTRATION

Approval history

2022-08-03Labeling · Supplement 1 · standardLetterAP
2021-02-01Type 3 - New Dosage Form · Original · standardLabelAP
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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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