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. 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 021498

Tradename:	ALINIA
Applicant:	Romark
Ingredient:	nitazoxanide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021498

Suppliers and Packaging for NDA: 021498

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498	NDA	Romark Laboratories, L.C.	67546-212	67546-212-21	1 BOTTLE, GLASS in 1 CARTON (67546-212-21) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	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	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Try a Trial	⤷ Try a Trial
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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