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Last Updated: April 23, 2024

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. It is available from two suppliers. 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. Three 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021497

Suppliers and Packaging for NDA: 021497

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALINIA	nitazoxanide	TABLET;ORAL	021497	NDA AUTHORIZED GENERIC	Lupin Pharmaceuticals, Inc.	43386-405	43386-405-03	30 BOTTLE, PLASTIC in 1 CARTON (43386-405-03) / 30 TABLET in 1 BOTTLE, PLASTIC
ALINIA	nitazoxanide	TABLET;ORAL	021497	NDA AUTHORIZED GENERIC	Lupin Pharmaceuticals, Inc.	43386-405	43386-405-12	12 BOTTLE, PLASTIC in 1 CARTON (43386-405-12) / 12 TABLET in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 21, 2004	TE:	AB	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	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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