MedPath
FDA Product

Nystatin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Nystatin

13668-595

Regulatory Information

13668-595

ANDA212557

C73584

September 6, 2022

USA

Nystatin Cream USP, 100,000 units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

916488547

Active Ingredients

ALUMINUM HYDROXIDE

Code: 5QB0T2IUN0

Class Code: IACT

CETEARETH-15

Code: 867H4YOZ8Z

Class Code: IACT

DIMETHICONE

Code: 92RU3N3Y1O

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

POLYOXYL 8 STEARATE

Code: 2P9L47VI5E

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PETROLATUM

Code: 4T6H12BN9U

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

NYSTATIN

Quantity: 100000 U in 1 g

Code: BDF1O1C72E

Class Code: ACTIB

Active Moieties

NYSTATIN

Code: BDF1O1C72E

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