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QuintilesIMS

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204178

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NDA 204178 describes NIACIN, which is a drug marketed by Amneal Pharms, Barr, Lannett, 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-three NDAs. It is available from twelve 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 204178

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204178

Ingredient-typeNicotinic Acids

Medical Subject Heading (MeSH) Categories for 204178

Suppliers and Packaging for NDA: 204178

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 204178 ANDA Amneal Pharmaceuticals of New York, LLC 65162-322 65162-322-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03)
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 204178 ANDA Amneal Pharmaceuticals of New York, LLC 65162-322 65162-322-50 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Dec 11, 2015TE:ABRLD:No


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