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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. There are three patents protecting this drug. Additional details are available on the ALINIA profile page.

The generic ingredient in ALINIA is nitazoxanide. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.

Summary for NDA: 021498

Tradename:
ALINIA
Applicant:
Romark
Ingredient:
nitazoxanide
Patents:3
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 27437-106-01 1 BOTTLE, GLASS in 1 CARTON (27437-106-01) > 60 mL in 1 BOTTLE, GLASS
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL 021498 NDA Lupin Pharma 27437-106 27437-106-02 1 BOTTLE, GLASS in 1 CARTON (27437-106-02) > 60 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Nov 22, 2002TE:RLD:Yes
Patent:5,968,961Patent Expiration:May 7, 2017Product Flag?Substance Flag?Delist Request?
Patent:6,117,894Patent Expiration:May 7, 2017Product Flag?Substance Flag?Delist Request?
Patent:5,965,590Patent Expiration:Jul 3, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED MAMMAL

Expired Orange Book Patents for NDA: 021498

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,387,598► subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20026,020,353► subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,859,038► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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