What is GRISEOFULVIN,ULTRAMICROSIZE used for?

GRISEOFULVIN,ULTRAMICROSIZE is an FDA-approved medication. See full prescribing information for approved uses.

Is GRISEOFULVIN,ULTRAMICROSIZE FDA approved?

Yes, GRISEOFULVIN,ULTRAMICROSIZE is FDA approved (first approved 2012-10-22) and manufactured by SIGMAPHARM LABS LLC.

Who makes GRISEOFULVIN,ULTRAMICROSIZE?

GRISEOFULVIN,ULTRAMICROSIZE is manufactured by SIGMAPHARM LABS LLC.

Data updated: Mar 10, 2026

GRISEOFULVIN,ULTRAMICROSIZE

GRISEOFULVIN, ULTRAMICROSIZE

Approved 2012-10-22

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Indications

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2012-10-22
Routes: ORAL
Dosage Forms: TABLET

Companies

SIGMAPHARM LABS LLC Novartis MOUNTAIN

Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE

GRISEOFULVIN,ULTRAMICROSIZE Approval History

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What GRISEOFULVIN,ULTRAMICROSIZE Treats

3 FDA approvals

Originally approved for its first indication in 2012 . Covers 3 distinct patient populations.

Other (3)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

GRISEOFULVIN,ULTRAMICROSIZE FDA Label Details

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Data Sources

FDA Approval: ANDA202545 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.