BUPROPION HYDROCHLORIDE از شرکت WATSON LABS INC

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

BUPROPION HYDROCHLORIDE از شرکت WATSON LABS INC

Abbreviated New Drug Application (ANDA): 077455

Company: WATSON LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued

None

No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Discontinued

None

No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL 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
03/12/2008 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
01/04/2021 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/04/2021 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/14/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

03/11/2013 SUPPL-20 REMS-Modified

Label is not available on this site.

04/16/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/22/2010 SUPPL-11 REMS-Proposal

Label is not available on this site.

11/16/2009 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/26/2009 SUPPL-7 Labeling

Label is not available on this site.

07/19/2010 SUPPL-4 Labeling

Label is not available on this site.

09/23/2008 SUPPL-1 Labeling

Label is not available on this site.

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