Drug application

TOLVAPTAN (TOLVAPTAN)

Drugs@FDA ANDA 211891 · ALKEM LABS LTD

Key facts

Drug name TOLVAPTAN
Active ingredients TOLVAPTAN
Application type ANDA
Application number 211891
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength 30MG
Marketing status Prescription
TE codes AB1
Reference listed drug No
Latest submission status date Sep 6, 2022

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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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