← FDA DRUG APPROVALS
FDA ANDA · ANDA203136
BUPRENORPHINE HCL AND NALOXONE HCL
buprenorphine and naloxone
Sponsor: AMNEAL PHARMS
APPLICATION
ANDA203136
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-22
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 52 · standardAP
2025-02-21REMS · Supplement 49AP
2024-03-20REMS · Supplement 43AP
2023-12-15Labeling · Supplement 46 · standardAP
2023-05-25Labeling · Supplement 44 · standardAP
2022-12-16REMS · Supplement 42AP
2022-06-17Labeling · Supplement 40 · standardAP
2022-06-17Labeling · Supplement 37 · standardAP
2022-06-14Labeling · Supplement 35 · standardAP
2022-05-03REMS · Supplement 38AP
2021-03-04Labeling · Supplement 30 · standardAP
2021-01-14Labeling · Supplement 26 · standardAP
2021-01-14Labeling · Supplement 25 · standardAP
2019-10-08Labeling · Supplement 21 · standardAP
2018-10-31REMS · Supplement 19AP
2018-02-01Labeling · Supplement 16 · standardAP
2018-02-01Labeling · Supplement 17 · standardAP
2018-01-31Labeling · Supplement 14 · standardAP
2017-05-23REMS · Supplement 13AP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 10 · standardAP
2016-07-07REMS · Supplement 9AP
2015-02-12REMS · Supplement 6AP
2015-02-05Labeling · Supplement 7 · standardAP
2013-09-04REMS · Supplement 5AP
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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