BUPRENORPHINE HYDROCHLORIDE از شرکت MYLAN

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 از شرکت MYLAN

Abbreviated New Drug Application (ANDA): 201066

Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Discontinued

None

No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG 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
03/06/2015 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
03/04/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-11 Labeling-Medication Guide, 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-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/31/2018 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-5 REMS-Modified

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/07/2016 SUPPL-2 REMS-Proposal

Label is not available on this site.

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