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FDA ANDA · ANDA203326
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
Sponsor: HIKMA
APPLICATION
ANDA203326
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-27
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 37 · standardAP
2025-02-21REMS · Supplement 36AP
2024-03-20REMS · Supplement 29AP
2023-12-15Labeling · Supplement 33 · standardAP
2023-06-06Labeling · Supplement 30 · standardAP
2022-12-16REMS · Supplement 27AP
2022-06-17Labeling · Supplement 25 · standardAP
2022-06-17Labeling · Supplement 23 · standardAP
2022-06-14Labeling · Supplement 21 · standardAP
2022-05-03REMS · Supplement 24AP
2021-03-04Labeling · Supplement 16 · standardAP
2019-10-07Labeling · Supplement 14 · standardAP
2018-10-31REMS · Supplement 11AP
2018-02-01Labeling · Supplement 10 · standardAP
2017-05-23REMS · Supplement 7AP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 5 · standardAP
2016-07-07REMS · Supplement 4AP
2015-02-12REMS · Supplement 2AP
2015-02-04Labeling · Supplement 3 · 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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