Wednesday, July 8, 2026

Drug profile · INN

miconazole nitrate

miconazole nitrate (MONISTAT 7) is a cytochrome p450 51 inhibitor. Associated with Teva Pharma GmbH. Route of administration: topical. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — miconazole nitrate
US status
approved
Class
Route
TOPICAL
Patents
0
Programs
1
Data quality
0.89

Quick answer

miconazole nitrate (MONISTAT 7) is a cytochrome p450 51 inhibitor. Associated with Teva Pharma GmbH. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN miconazole nitrate
Brand MONISTAT 7
Mechanism Cytochrome P450 51 inhibitor
Target Lanosterol 14-alpha demethylase
Route TOPICAL
Formulation CREAM

Mechanism of action

Cytochrome P450 51 inhibitor

Primary target: Lanosterol 14-alpha demethylase

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. prefilled liquid etanercept(Yisaipu) Phase 3 · Sunshine Guojian Pharmaceutical · Ankylosing Spondylitis

Related & competitor drugs

  1. clotrimazole Cytochrome P450 51 inhibitor
  2. efinaconazole Lanosterol 14-alpha demethylase inhibitor
  3. fluconazole Cytochrome P450 51 inhibitor
  4. itraconazole Cytochrome P450 51 inhibitor
  5. ketoconazole Antiinfectives for systemic use (J02)
  6. posaconazole Antiinfectives for systemic use (J02)

Frequently asked questions

What is miconazole nitrate?

miconazole nitrate (MONISTAT 7) is a cytochrome p450 51 inhibitor. Associated with Teva Pharma GmbH. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for miconazole nitrate?

MONISTAT 7 is a marketed brand name for miconazole nitrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of miconazole nitrate?

miconazole nitrate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.