Drug application

MONISTAT 3 (MICONAZOLE NITRATE)

Drugs@FDA NDA 018888 · MEDTECH PRODUCTS

Key facts

Drug name MONISTAT 3
Active ingredients MICONAZOLE NITRATE
Application type NDA
Application number 018888
Company MEDTECH PRODUCTS
Dosage forms SUPPOSITORY, VAGINAL
Strength 200MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Aug 15, 1984

At a glance

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