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Medicines · US (FDA)

FDA 2026

Combinations of antibacterials

Nystatin

Approved 5 Feb 2026OralSuspension

The FDA lists this product in 59 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: NYSTATIN 100,000 UNITS/ML

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

NYSTATIN 100,000 UNITS/GM · PowderANDA208581-001 · Prescription
NYSTATIN 100,000 UNITS/GM · PowderANDA208838-001 · Prescription
NYSTATIN 100,000 UNITS/GM · CreamANDA219527-001 · Prescription
NYSTATIN 500,000 UNITS · TabletANDA062525-001 · Discontinued
NYSTATIN 100% · PowderANDA062613-001 · Discontinued
NYSTATIN 500,000 UNITS · TabletANDA062838-001 · Discontinued
NYSTATIN 100,000 UNITS/ML · SuspensionANDA064142-001 · Discontinued
NYSTATIN 100,000 UNITS/ML · SuspensionANDA064142-002 · Discontinued
NYSTATIN 100,000 UNITS/GM · PowderANDA065203-001 · Prescription
NYSTATIN 100,000 UNITS/GM · CreamANDA065315-001 · Discontinued
NYSTATIN 100,000 UNITS/GM · CreamANDA207733-001 · Prescription
NYSTATIN 100,000 UNITS/GM · OintmentANDA213826-001 · Prescription

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

NYSTATIN 100,000 UNITS/ML · SuspensionANDA214346-001 · Prescription

NYSTATIN 100,000 UNITS/ML · SuspensionThis page

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062832-001 · Prescription

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062835-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA064042-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · PowderANDA065183-001 · Prescription

NYSTATIN 100,000 UNITS/GM · CreamANDA213566-001 · Prescription

NYSTATIN 100,000 UNITS/GM · CreamANDA061966-001 · Prescription

NYSTATIN 500,000 UNITS · TabletANDA062065-001 · Discontinued

NYSTATIN 100,000 UNITS · TabletANDA062509-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062670-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062776-001 · Discontinued

NYSTATIN 500,000 UNITS · TabletANDA062474-001 · Prescription

NYSTATIN 500,000 UNITS · TabletANDA062506-001 · Prescription

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062512-001 · Prescription

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062876-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · OintmentANDA211838-001 · Prescription

NYSTATIN 100,000 UNITS/GM · CreamANDA062457-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062571-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA065148-001 · Prescription

NYSTATIN 100,000 UNITS/ML · SuspensionANDA203621-001 · Prescription

NYSTATIN 100,000 UNITS/GM · OintmentANDA209114-001 · Prescription

NYSTATIN 100,000 UNITS/GM · CreamANDA062225-001 · Prescription

NYSTATIN 100,000 UNITS/GM · OintmentANDA062472-001 · Prescription

NYSTATIN 100,000 UNITS · TabletANDA062502-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · CreamANDA062949-001 · Prescription

NYSTATIN 100,000 UNITS/GM · PowderANDA065321-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · CreamANDA212557-001 · Prescription

NYSTATIN 500,000 UNITS · TabletANDA062402-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062541-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · PowderANDA065175-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · OintmentANDA209082-001 · Prescription

NYSTATIN 100,000 UNITS · TabletANDA061965-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · OintmentANDA062124-002 · Prescription

NYSTATIN 100,000 UNITS · TabletANDA062459-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062517-001 · Prescription

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062518-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · OintmentANDA062840-001 · Prescription

NYSTATIN 100,000 UNITS/GM · PowderANDA065138-001 · Prescription

NYSTATIN 100,000 UNITS/GM · CreamANDA062129-001 · Prescription

NYSTATIN 100,000 UNITS · TabletANDA062176-001 · Discontinued

NYSTATIN 100,000 UNITS/ML · SuspensionANDA062349-001 · Discontinued

NYSTATIN 100,000 UNITS · TabletANDA062460-001 · Discontinued

NYSTATIN 100,000 UNITS · TabletANDA062615-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · OintmentANDA207767-001 · Prescription

NYSTATIN 500,000 UNITS · TabletANDA062524-001 · Discontinued

NYSTATIN 100,000 UNITS/GM · CreamANDA064022-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA220367.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Nystatin
Drug class: Combinations of antibacterials, Antibiotics
Route: Oral
Dosage form: Suspension
Applicant: Steranco Hlthcare
Status: Prescription
FDA approval: 5 Feb 2026
Application: ANDA220367-001
RxCUI: 7597