← FDA DRUG APPROVALS
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
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.