APPLICATION
ANDA217821
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-27
LATEST ACTION
2024-03-27
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, RETROBULBAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
Approval history
2024-03-27UNKNOWN · Original · standardAP
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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