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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Daiichi Sankyo
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Moodys
Cantor Fitzgerald
Cipla
Queensland Health
Mallinckrodt

Generated: April 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, 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 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 American Health Packaging 68084-773 N 68084-773-21
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090446 ANDA Lupin Pharmaceuticals, Inc. 68180-223 N 68180-223-01

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:

Medtronic
Deloitte
Queensland Health
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Federal Trade Commission
McKesson
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