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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021498

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NDA 021498 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. Two suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.

Summary for 021498

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Nov 22, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021498

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Get Started Free	⤷ Get Started Free
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Get Started Free	⤷ Get Started Free
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Get Started Free	⤷ Get Started Free
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Get Started Free	⤷ Get Started Free
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Get Started Free	⤷ Get Started Free
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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