Drug application

BROMFENAC SODIUM (BROMFENAC SODIUM)

Drugs@FDA ANDA 214340 · ALEMBIC

Key facts

Drug name BROMFENAC SODIUM
Active ingredients BROMFENAC SODIUM
Application type ANDA
Application number 214340
Company ALEMBIC
Dosage forms SOLUTION/DROPS, OPHTHALMIC
Strength EQ 0.07% ACID
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 8, 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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