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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218005

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NDA 218005 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 218005

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

Pharmacology for NDA: 218005

Medical Subject Heading (MeSH) Categories for 218005

Antifungal Agents
Antimetabolites

Suppliers and Packaging for NDA: 218005

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUCYTOSINE	flucytosine	CAPSULE;ORAL	218005	ANDA	Laurus Labs Limited	42385-983	42385-983-01	100 CAPSULE in 1 BOTTLE (42385-983-01)
FLUCYTOSINE	flucytosine	CAPSULE;ORAL	218005	ANDA	Laurus Labs Limited	42385-983	42385-983-27	10 BLISTER PACK in 1 CARTON (42385-983-27) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jul 23, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Jul 23, 2025	TE:	AB	RLD:	No

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