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Details for Generic Name: niacin

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Niacin is the generic ingredient in eight branded drugs marketed by Medpointe Pharm Hlc, Barr, Lupin Ltd, Sun Pharma Global, Abbvie, Everylife, Halsey, Hikma Pharms Llc, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Upsher Smith, Sanofi Aventis Us, and Intl Minerals, and is included in twenty-six NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for niacin. Nine suppliers are listed for this compound.

Summary for Generic Name: niacin

Drug Master File Entries: see list12
Suppliers: see list9
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: niacin

Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid

Clinical Trials for: niacin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
TABLET, EXTENDED RELEASE;ORAL020381Jul 28, 1997RXYes7,998,506<disabled><disabled>
Impax Labs
TABLET;ORAL083115Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,080,428<disabled><disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Jul 28, 2010RXYes7,011,848<disabled><disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,746,691<disabled>Y<disabled>
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