Last Updated: May 11, 2026

Details for New Drug Application (NDA): 021497

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NDA 021497 describes ALINIA, which is a drug marketed by Romark and is included in two NDAs. Additional details are available on the ALINIA profile page.

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

Summary for 021497

Tradename:	ALINIA
Applicant:	Romark
Ingredient:	nitazoxanide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 21, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021497

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	5,968,961	⤷ Start Trial
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	5,387,598	⤷ Start Trial
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	6,020,353	⤷ Start Trial
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	5,578,621	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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