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Serving leading biopharmaceutical companies globally:

Novartis
Johnson and Johnson
Teva
Chubb
AstraZeneca
Covington
QuintilesIMS
Fish and Richardson
Julphar
McKinsey

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090446

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NDA 090446 describes NIACIN, which is a drug marketed by Amneal Pharms, Barr, Lannett, Lupin Ltd, Sun Pharma Global, Everylife, Halsey, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in twenty-three NDAs. It is available from thirteen suppliers. Additional details are available on the NIACIN profile page.

The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 090446
Tradename:NIACIN
Applicant:Lupin Ltd
Ingredient:niacin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090446
Ingredient-typeNicotinic Acids
Medical Subject Heading (MeSH) Categories for 090446
Suppliers and Packaging for NDA: 090446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090446 ANDA LUPIN LIMITED 57297-223 57297-223-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57297-223-01)
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090446 ANDA LUPIN LIMITED 57297-223 57297-223-03 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (57297-223-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Mar 20, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
Healthtrust
Accenture
Argus Health
Teva
Colorcon
Federal Trade Commission
Chinese Patent Office

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