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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207536

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NDA 207536 describes FLUCYTOSINE, which is a drug marketed by Aurobindo Pharma Ltd, Hikma, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma, and is included in six NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the flucytosine profile page.

Summary for 207536

Tradename:	FLUCYTOSINE
Applicant:	Strides Pharma
Ingredient:	flucytosine
Patents:	0

Medical Subject Heading (MeSH) Categories for 207536

Antifungal Agents
Antimetabolites

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jun 18, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Jun 18, 2018	TE:		RLD:	No

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