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Serving 500+ biopharmaceutical companies globally:

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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021726

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NDA 021726 describes NIRAVAM, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NIRAVAM profile page.

The generic ingredient in NIRAVAM is alprazolam. There are fifteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for NDA: 021726

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021726

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 021726

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIRAVAM
alprazolam
TABLET, ORALLY DISINTEGRATING;ORAL 021726 NDA STAT RX USA LLC 16590-938 16590-938-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (16590-938-30)
NIRAVAM
alprazolam
TABLET, ORALLY DISINTEGRATING;ORAL 021726 NDA STAT RX USA LLC 16590-938 16590-938-60 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (16590-938-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 19, 2005TE:RLD:Yes
Patent:6,024,981Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,221,392Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 19, 2005TE:RLD:Yes
Patent:6,024,981Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

McKinsey
Medtronic
Harvard Business School
Boehringer Ingelheim
QuintilesIMS
Cipla
US Department of Justice
AstraZeneca
Healthtrust
Mallinckrodt

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