BUPROPION HYDROCHLORIDE از شرکت IMPAX LABS

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 IMPAX LABS

Abbreviated New Drug Application (ANDA): 076711

Company: IMPAX LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription

AB1

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
12/03/2004 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-40 Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-31 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

02/21/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/21/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/18/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/08/2010 SUPPL-11 REMS-Proposal

Label is not available on this site.

01/27/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/16/2008 SUPPL-7 Labeling

Label is not available on this site.

10/05/2006 SUPPL-5 Labeling

Label is not available on this site.

02/14/2006 SUPPL-3 Labeling

Label is not available on this site.

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 200MG

TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 079095 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 091459 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076711 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 206674 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202304 PRINSTON INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075932 SANDOZ
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205794 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078866 SUN PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 211347 YICHANG HUMANWELL
WELLBUTRIN SR BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020358 GLAXOSMITHKLINE
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