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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206550

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NDA 206550 describes FLUCYTOSINE, which is a drug marketed by Aurobindo Pharma Ltd, Hikma, Laurus, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the FLUCYTOSINE profile page.

The generic ingredient in FLUCYTOSINE is flucytosine. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the flucytosine profile page.

Summary for 206550

Tradename:	FLUCYTOSINE
Applicant:	Hikma
Ingredient:	flucytosine
Patents:	0

Medical Subject Heading (MeSH) Categories for 206550

Antifungal Agents
Antimetabolites

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Oct 17, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Oct 17, 2017	TE:		RLD:	No

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