Drug application

NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL HYDROCHLORIDE)

Drugs@FDA ANDA 211053 · AUROBINDO PHARMA LTD

Key facts

Drug name NEBIVOLOL HYDROCHLORIDE
Active ingredients NEBIVOLOL HYDROCHLORIDE
Application type ANDA
Application number 211053
Company AUROBINDO PHARMA LTD
Dosage forms TABLET, ORAL
Strength EQ 2.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 17, 2021

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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