Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090279
Company: RUBICON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription AB 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
06/10/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

10/09/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/31/2018 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-7 REMS-Modified

Label is not available on this site.

12/16/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/07/2016 SUPPL-4 REMS-Modified

Label is not available on this site.

BUPRENORPHINE HYDROCHLORIDE

TABLET;SUBLINGUAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 090819 ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 090622 ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 078633 HIKMA
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 207276 RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 090279 RUBICON
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 201760 SUN PHARM

TABLET;SUBLINGUAL; EQ 8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription No AB 090819 ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription No AB 090622 ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription No AB 078633 HIKMA
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription No AB 207276 RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription No AB 090279 RUBICON
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET;SUBLINGUAL Prescription No AB 201760 SUN PHARM

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