Alinia

NDA 21497, held by Romark. Nitazoxanide.

As of Nov 14, 2026, NDA 21497 (Alinia), held by Romark, was first approved by FDA on Jul 21, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 21, 2004
Review: Priority
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 21, 2004	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alinia500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nitazoxanide	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Jan 19, 2022	Supplement 18Labeling · Standard review	Approved	Label
Dec 16, 2021	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 11, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Mar 3, 2015	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 5, 2012	Supplement 3Manufacturing · Priority review	Approved	None posted
Jul 21, 2004	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21497
Drugs@FDA: Overview at FDA
Company: Romark Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters