Details for New Drug Application (NDA): 218701

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NDA 218701 describes NITAZOXANIDE, which is a drug marketed by Ani Pharms, Annora Pharma, and Rising, and is included in three NDAs. It is available from two suppliers. Additional details are available on the NITAZOXANIDE profile page.

The generic ingredient in NITAZOXANIDE is nitazoxanide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.

Summary for 218701

Tradename:	NITAZOXANIDE
Applicant:	Annora Pharma
Ingredient:	nitazoxanide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 15, 2025	TE:	AB	RLD:	No

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