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FDA ANDA · ANDA207000
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
Sponsor: SPECGX LLC
APPLICATION
ANDA207000
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-13
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 39 · standardAP
2025-02-21REMS · Supplement 38AP
2024-03-20REMS · Supplement 29AP
2023-12-15Labeling · Supplement 35 · standardAP
2023-06-14Labeling · Supplement 25 · standardAP
2023-06-14Labeling · Supplement 30 · standardAP
2022-12-16REMS · Supplement 27AP
2022-06-17Labeling · Supplement 21 · standardAP
2022-06-17Labeling · Supplement 24 · standardAP
2022-06-14Labeling · Supplement 16 · standardAP
2022-05-03REMS · Supplement 22AP
2021-03-04Labeling · Supplement 9 · standardAP
2021-02-16Labeling · Supplement 7 · standardAP
2019-10-08Labeling · Supplement 4 · standardAP
2019-09-23Labeling · Supplement 2 · standardAP
2018-10-31REMS · Supplement 1AP
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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