Drug application

ACYCLOVIR (ACYCLOVIR)

Drugs@FDA ANDA 077309 · APOTEX

Key facts

Drug name ACYCLOVIR
Active ingredients ACYCLOVIR
Application type ANDA
Application number 077309
Company APOTEX
Dosage forms TABLET, ORAL
Strength 400MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Sep 29, 2005

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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