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FDA ANDA · ANDA204842

BUPIVACAINE HYDROCHLORIDE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA204842
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-11
LATEST ACTION
2021-02-11
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, RETROBULBAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION

Approval history

2021-02-11UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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