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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Healthtrust
Baxter
Daiichi Sankyo
Fish and Richardson
Medtronic
Express Scripts
Cipla

Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076250

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NDA 076250 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 fourteen 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 076250
Tradename:NIACIN
Applicant:Barr
Ingredient:niacin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076250
Ingredient-typeNicotinic Acids
Medical Subject Heading (MeSH) Categories for 076250
Suppliers and Packaging for NDA: 076250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 076250 ANDA Teva Pharmaceuticals USA, Inc. 0093-7394 N 0093-7394-86
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 076250 ANDA Teva Pharmaceuticals USA, Inc. 0093-7394 N 0093-7394-98

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Apr 14, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Accenture
Chubb
Federal Trade Commission
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Argus Health
Julphar
Cerilliant
McKinsey

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