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General MedicationsTOPICALStandard

METRONIDAZOLE

METRONIDAZOLE

Standard Dose
0.75%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview METRONIDAZOLE is listed in Drugs@FDA under application 220095 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METRONIDAZOLE Form and strength GEL;TOPICAL - 0.75% Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2026-02-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview METRONIDAZOLE is listed in Drugs@FDA under application 220095 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METRONIDAZOLE Form and strength GEL;TOPICAL - 0.75% Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2026-02-13 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.