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FDA Drug information

NYSTATIN

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Effective Time

20221031

Version

3

Spl Product Data Elements

NYSTATIN nystatin NYSTATIN NYSTATIN TALC

Application Number

ANDA208581

Brand Name

NYSTATIN

Generic Name

nystatin

Product Ndc

70771-1585

Product Type

HUMAN PRESCRIPTION DRUG

Route

TOPICAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1585-1 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 15 GRAMS NDC 70771-1585-2 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 30 GRAMS NDC 70771-1585-3 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 60 GRAMS 15 gm label 30 gm label 60 gm label

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