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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201633
Company: SUN PHARM
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
08/05/2016 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2022 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/15/2022 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/03/2022 SUPPL-21 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

08/23/2021 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/04/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/09/2019 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/31/2018 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/31/2018 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-2 REMS-Modified

Label is not available on this site.

03/23/2017 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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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