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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200484

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NDA 200484 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 fifteen 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-three suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 200484
Tradename:NIACIN
Applicant:Sun Pharma Global
Ingredient:niacin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200484
Ingredient-typeNicotinic Acids
Medical Subject Heading (MeSH) Categories for 200484
Suppliers and Packaging for NDA: 200484
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 200484 ANDA Sun Pharma Global FZE 47335-539 N 47335-539-08
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 200484 ANDA Sun Pharma Global FZE 47335-539 N 47335-539-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 23, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Apr 23, 2014TE:ABRLD:No

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