Drug application

THEOPHYLLINE (THEOPHYLLINE)

Drugs@FDA ANDA 216276 · AMNEAL

Key facts

Drug name THEOPHYLLINE
Active ingredients THEOPHYLLINE
Application type ANDA
Application number 216276
Company AMNEAL
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 300MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 20, 2023

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 10–99 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

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