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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203136
Company: AMNEAL PHARMS
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
02/22/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203136Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

05/25/2023 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

03/20/2024 SUPPL-43 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2022 SUPPL-42 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

05/03/2022 SUPPL-38 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/14/2022 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-30 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/14/2021 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/14/2021 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/31/2018 SUPPL-19 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/01/2018 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/31/2018 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/23/2017 SUPPL-13 REMS-Modified

Label is not available on this site.

12/16/2016 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/07/2016 SUPPL-9 REMS-Modified

Label is not available on this site.

02/05/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/12/2015 SUPPL-6 REMS-Proposal

Label is not available on this site.

09/04/2013 SUPPL-5 REMS-Proposal

Label is not available on this site.

04/18/2014 SUPPL-3 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203136Orig1s003ltr.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
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