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Colorcon
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UBS
Farmers Insurance
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Fuji
US Department of Justice
Citi
Chubb

Generated: June 21, 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, Aurobindo Pharma Ltd, Barr, Jubilant Generics, Lannett Co Inc, 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-five NDAs. It is available from fifteen 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-three 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 E 57297-223-01
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090446 ANDA LUPIN LIMITED 57297-223 E 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 hundreds of leading biopharmaceutical companies globally:

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