BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت TEVA PHARMS USA

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت TEVA PHARMS USA

Abbreviated New Drug Application (ANDA): 091149

Company: TEVA PHARMS USA

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 Discontinued

None

No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Discontinued

None

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
09/08/2014 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-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/31/2018 SUPPL-13 REMS – MODIFIED – D-N-A

Label is not available on this site.

02/01/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/01/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-9 REMS-Modified

Label is not available on this site.

12/16/2016 SUPPL-8 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-3 REMS-Modified

Label is not available on this site.

02/05/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/12/2015 SUPPL-1 REMS-Modified

Label is not available on this site.

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بخوانید  BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت RHODES PHARMS
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