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Drugs@FDA: FDA-Approved Drugs

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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
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
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