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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
Daiichi Sankyo
Farmers Insurance
Cipla
Mallinckrodt
Accenture
Chubb
UBS

Generated: April 20, 2018

DrugPatentWatch Database Preview

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 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 021498
Tradename:ALINIA
Applicant:Romark
Ingredient:nitazoxanide
Patents:0
Therapeutic Class:Antiparasitics
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 Lupin Pharma 27437-106 N 27437-106-01
ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498 NDA Lupin Pharma 27437-106 N 27437-106-02

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 ➤ Sign Up ➤ Sign Up
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Sign Up ➤ Sign Up
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Sign Up ➤ Sign Up
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ 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:

Covington
Merck
Baxter
Boehringer Ingelheim
US Army
Express Scripts
Moodys
Cerilliant
Queensland Health

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