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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
Merck
Farmers Insurance
Covington
Accenture
QuintilesIMS
Daiichi Sankyo
Boehringer Ingelheim

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201273

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NDA 201273 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, 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-four 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. Eighteen suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 201273
Tradename:NIACIN
Applicant:Sun Pharma Global
Ingredient:niacin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201273
Ingredient-typeNicotinic Acids
Medical Subject Heading (MeSH) Categories for 201273
Suppliers and Packaging for NDA: 201273
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 201273 ANDA Sun Pharma Global FZE 47335-614 N 47335-614-88
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 201273 ANDA Sun Pharma Global FZE 47335-614 N 47335-614-81

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Apr 23, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Harvard Business School
Argus Health
QuintilesIMS
Teva
Daiichi Sankyo
Express Scripts
Citi

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