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FDA ANDA · ANDA206953

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA206953
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-17
LATEST ACTION
2022-12-16
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL

Approval history

2022-12-16REMS · Supplement 11AP
2022-06-17Labeling · Supplement 8 · standardAP
2022-06-17Labeling · Supplement 10 · standardAP
2022-06-14Labeling · Supplement 7 · standardAP
2022-05-03REMS · Supplement 9AP
2021-03-04Labeling · Supplement 1 · standardAP
2020-07-17UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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