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FDA ANDA · ANDA207183

BUPIVACAINE HYDROCHLORIDE

Sponsor: EUGIA PHARMA

APPLICATION
ANDA207183
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-13
LATEST ACTION
2023-03-10
ROUTE
INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION

Approval history

2023-03-10Labeling · Supplement 4 · standardAP
2020-07-21Labeling · Supplement 2 · standardAP
2016-05-13UNKNOWN · Original · standardAP
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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