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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Teva
QuintilesIMS
Chinese Patent Office
Covington
Julphar
Fish and Richardson
Merck
Johnson and Johnson

Generated: May 26, 2018

DrugPatentWatch Database Preview

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 three 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
Therapeutic Class:Antiparasitics
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 Romark Laboratories, L.C. 67546-111 N 67546-111-12
ALINIA nitazoxanide TABLET;ORAL 021497 NDA Romark Laboratories, L.C. 67546-111 N 67546-111-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 21, 2004TE:RLD:Yes

Expired US Patents for NDA 021497

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Sign Up ➤ Sign Up
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Sign Up ➤ Sign Up
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Sign Up ➤ Sign Up
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Medtronic
McKesson
US Army
Chinese Patent Office
McKinsey
Queensland Health
Fish and Richardson
Cantor Fitzgerald

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