BUPROPION HYDROCHLORIDE از شرکت APNAR PHARMA LP

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 APNAR PHARMA LP

Abbreviated New Drug Application (ANDA): 075584

Company: APNAR PHARMA LP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription

AB

No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription

AB

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
02/07/2000 ORIG-1 Approval

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75584ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75584_Bupropion.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

05/16/2015 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

03/28/2012 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

03/27/2012 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/08/2010 SUPPL-32 REMS-Proposal

Label is not available on this site.

03/04/2010 SUPPL-31 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/16/2009 SUPPL-27 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/19/2007 SUPPL-24 Labeling

Label is not available on this site.

12/19/2008 SUPPL-23 Labeling

Label is not available on this site.

01/16/2008 SUPPL-20 Labeling

Label is not available on this site.

02/08/2007 SUPPL-19 Labeling

Label is not available on this site.

02/08/2007 SUPPL-14 Labeling

Label is not available on this site.

06/01/2005 SUPPL-12 Labeling

Label is not available on this site.

02/04/2004 SUPPL-9 Labeling

Label is not available on this site.

11/05/2002 SUPPL-7 Labeling

Label is not available on this site.

01/18/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

BUPROPION HYDROCHLORIDE

TABLET;ORAL; 75MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 203013 ALEMBIC PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 075584 APNAR PHARMA LP
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 076143 APOTEX INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 208606 CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 206975 HERITAGE PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 207389 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 207403 MICRO LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 075491 MYLAN

TABLET;ORAL; 100MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 203013 ALEMBIC PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075584 APNAR PHARMA LP
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 076143 APOTEX INC
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 208606 CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 206975 HERITAGE PHARMA
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207389 INVAGEN PHARMS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207403 MICRO LABS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075491 MYLAN
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