Drug application

TETRACAINE HYDROCHLORIDE (TETRACAINE HYDROCHLORIDE)

Drugs@FDA ANDA 217227 · SOMERSET THERAPS LLC

Key facts

Drug name TETRACAINE HYDROCHLORIDE
Active ingredients TETRACAINE HYDROCHLORIDE
Application type ANDA
Application number 217227
Company SOMERSET THERAPS LLC
Dosage forms SOLUTION, OPHTHALMIC
Strength 0.5%
Marketing status Prescription
TE codes AB1
Reference listed drug No
Latest submission status date Dec 20, 2024

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 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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