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Last Updated: April 19, 2021

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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:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Nov 22, 2002TE:RLD:Yes

Expired US Patents for NDA 021498

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

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