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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201760
Company: SUN PHARM
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
01/29/2016 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201760Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/05/2023 SUPPL-33 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/20/2024 SUPPL-32 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2022 SUPPL-29 REMS - MODIFIED - D-N-A

Label is not available on this site.

11/16/2022 SUPPL-27 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/17/2022 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

06/13/2022 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/03/2022 SUPPL-23 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-22 Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

06/13/2022 SUPPL-20 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/04/2021 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/16/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/09/2019 SUPPL-12 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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-6 REMS-Modified

Label is not available on this site.

03/24/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/07/2016 SUPPL-1 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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