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): 077415

Company: IMPAX LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription

AB3

No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG 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
12/15/2006 ORIG-1 Approval

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/07/2020 SUPPL-36 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/26/2017 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2017 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2017 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

12/01/2014 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

03/29/2012 SUPPL-18 Labeling-Package Insert

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf

08/30/2011 SUPPL-17 Labeling-Package Insert

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf

05/13/2010 SUPPL-15 REMS-Proposal

Label is not available on this site.

01/22/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/15/2009 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/26/2008 SUPPL-7 Labeling

Label is not available on this site.

11/26/2008 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/2008 SUPPL-5 Labeling

Label is not available on this site.

09/17/2007 SUPPL-3 Labeling

Label is not available on this site.

09/17/2007 SUPPL-2 Labeling

Label is not available on this site.

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 150MG

TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210497 ACCORD HLTHCARE
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077715 ACTAVIS LABS FL INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 211020 ADAPTIS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207224 ANBISON LAB
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077284 ANCHEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077415 IMPAX LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 206556 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 090693 LUPIN LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 207479 SCIEGEN PHARMS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 208652 SINOTHERAPEUTICS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 200216 SUN PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210081 TWI PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 077285 WATSON LABS INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202189 WOCKHARDT LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210015 YICHANG HUMANWELL
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 211200 ZHEJIANG JUTAI PHARM
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 201567 ZYDUS PHARMS
WELLBUTRIN XL BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021515 BAUSCH
حتما بخوانید : AFAXIN از شرکت STERLING WINTHROP
بخوانید  COSOPT PF از شرکت AKORN
به بالای صفحه بردن