Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021742
Company: ALLERGAN
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 |