APPLICATION
ANDA219401
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-18
LATEST ACTION
2025-12-18
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-18UNKNOWN · 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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