FDA ANDA · ANDA221145
BUPRENORPHINE HYDROCHLORIDE
Sponsor: GLAND
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APPLICATION
ANDA221145
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-15
LATEST ACTION
2026-10-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-10-15UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →