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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Queensland Health
Colorcon
QuintilesIMS
Healthtrust
Cantor Fitzgerald
Daiichi Sankyo
McKesson
Harvard Business School

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203578

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NDA 203578 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 203578
Tradename:NIACIN
Applicant:Amneal Pharms
Ingredient:niacin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203578
Ingredient-typeNicotinic Acids
Medical Subject Heading (MeSH) Categories for 203578
Suppliers and Packaging for NDA: 203578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578 ANDA Marlex Pharmaceuticals Inc 10135-612 N 10135-612-05
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578 ANDA Marlex Pharmaceuticals Inc 10135-612 N 10135-612-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 24, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Jul 24, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Boehringer Ingelheim
Cerilliant
Daiichi Sankyo
Cipla
Citi
Farmers Insurance
Argus Health

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