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FDA ANDA · ANDA209087

BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE

Sponsor: B BRAUN MEDICAL

APPLICATION
ANDA209087
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-02
LATEST ACTION
2024-10-25
ROUTE
SUBARACHNOID, SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · SPINAL

Approval history

2024-10-25Labeling · Supplement 2 · standardAP
2019-04-02UNKNOWN · 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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