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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204431
Company: ETHYPHARM USA CORP
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 Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG 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
10/16/2015 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204431Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204431Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

06/26/2023 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

03/20/2024 SUPPL-31 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2022 SUPPL-27 REMS - MODIFIED - D-N-A

Label is not available on this site.

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

Label is not available on this site.

05/03/2022 SUPPL-25 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/16/2022 SUPPL-22 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

03/15/2021 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/09/2019 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/31/2018 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-12 REMS-Modified

Label is not available on this site.

01/31/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

10/31/2016 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

07/07/2016 SUPPL-5 REMS-Modified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/16/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204431Orig1s000lbl.pdf

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

TABLET;SUBLINGUAL; EQ 2MG BASE;EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 091422 ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 214930 ALKEM LABS LTD
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 203136 AMNEAL PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 204431 ETHYPHARM USA CORP
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 203326 HIKMA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 205022 LANNETT CO INC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 205601 RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 207000 SPECGX LLC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 201633 SUN PHARM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 209069 WES PHARMA INC

TABLET;SUBLINGUAL; EQ 8MG BASE;EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 091422 ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 214930 ALKEM LABS LTD
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 203136 AMNEAL PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 204431 ETHYPHARM USA CORP
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 203326 HIKMA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 205022 LANNETT CO INC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 205601 RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 207000 SPECGX LLC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 201633 SUN PHARM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 209069 WES PHARMA INC
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