Drug application

VAGISTAT-1 (TIOCONAZOLE)

Drugs@FDA NDA 020676 · COMBE

Key facts

Drug name VAGISTAT-1
Active ingredients TIOCONAZOLE
Application type NDA
Application number 020676
Company COMBE
Dosage forms OINTMENT, VAGINAL
Strength 6.5%
Marketing status Over-the-counter
Reference listed drug Yes
Latest submission class Type 8 - Partial Rx to OTC Switch
Latest submission status date Feb 11, 1997

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • Yes 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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