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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206953
Company: MAYNE PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Discontinued None No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/17/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2022 SUPPL-11 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/03/2022 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/14/2022 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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