Last Updated: November 13, 2026

Details for New Drug Application (NDA): 061445

NDA 061445 describes NILSTAT, which is a drug marketed by Lederle, Strides Pharma Intl, and Chartwell Molecules, and is included in six NDAs. It is available from two suppliers. Additional details are available on the NILSTAT profile page.

The generic ingredient in NILSTAT is nystatin. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the nystatin profile page.

Summary for 061445

Tradename:	NILSTAT
Applicant:	Lederle
Ingredient:	nystatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 061445

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	100,000 UNITS/GM
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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