APPLICATION
ANDA217792
TYPE
ANDA
ORIGINAL APPROVAL
2023-11-20
LATEST ACTION
2023-11-20
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
2023-11-20UNKNOWN · 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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