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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 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: 021497

Tradename:
ALINIA
Applicant:
Romark
Ingredient:
nitazoxanide
Patents:1
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 67546-111-12 1 BOTTLE, PLASTIC in 1 CARTON (67546-111-12) > 30 TABLET in 1 BOTTLE, PLASTIC
ALINIA
nitazoxanide
TABLET;ORAL 021497 NDA Romark Laboratories, L.C. 67546-111 67546-111-14 1 BOTTLE, PLASTIC in 1 CARTON (67546-111-14) > 12 TABLET in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 21, 2004TE:RLD:Yes
Patent:5,968,961Patent Expiration:May 7, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021497

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 20045,387,598► subscribe
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 20046,020,353► subscribe
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 20045,578,621► subscribe
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