BYSTOLIC از شرکت ALLERGAN

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

BYSTOLIC از شرکت ALLERGAN

New Drug Application (NDA): 021742

Company: ALLERGAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription

AB

Yes No
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription

AB

Yes No
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription

AB

Yes No
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription

AB

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/17/2007 ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021742s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021742s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2017 SUPPL-22 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021742Orig1s022ltr.pdf

04/20/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/27/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/20/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/19/2012 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/14/2011 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021742s013ltr.pdf

02/19/2010 SUPPL-7 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021742s007ltr.pdf

10/08/2008 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2017 SUPPL-22

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf
12/14/2011 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf
02/19/2010 SUPPL-7

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf

BYSTOLIC

TABLET;ORAL; EQ 2.5MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III

TABLET;ORAL; EQ 5MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III

TABLET;ORAL; EQ 10MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III

TABLET;ORAL; EQ 20MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III
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