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FDA ANDA · ANDA209069
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
Sponsor: WES PHARMA INC
APPLICATION
ANDA209069
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-17
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 16 · standardAP
2025-02-21REMS · Supplement 15AP
2024-03-20REMS · Supplement 10AP
2023-12-15Labeling · Supplement 13 · standardAP
2023-06-13Labeling · Supplement 11 · standardAP
2022-12-16REMS · Supplement 9AP
2022-06-17Labeling · Supplement 5 · standardAP
2022-06-17Labeling · Supplement 8 · standardAP
2022-05-03REMS · Supplement 6AP
2021-03-04Labeling · Supplement 2 · 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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