Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021742
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription None Yes No
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription None Yes No
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription None Yes No
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription None 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
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-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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