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Serving 500+ biopharmaceutical companies globally:

Cipla
Cerilliant
Cantor Fitzgerald
Harvard Business School
US Department of Justice
Mallinckrodt
Chinese Patent Office
QuintilesIMS
Deloitte
AstraZeneca

Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200484

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NDA 200484 describes NIACIN, which is a drug marketed by Everylife, Watson Labs, Sandoz, Impax Labs, Hikma Pharms Llc, Mk Labs, Wockhardt, Tablicaps, Lupin Ltd, Barr, Halsey, Purepac Pharm, Sun Pharma Global, Amneal Pharms, Ivax Sub Teva Pharms, and Lannett, and is included in twenty-three NDAs. It is available from eleven 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-one suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for NDA: 200484

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

Pharmacology for NDA: 200484

Ingredient-typeNicotinic Acids

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 47335-539-08 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08)
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 200484 ANDA Sun Pharma Global FZE 47335-539 47335-539-18 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18)

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

McKinsey
Fuji
Teva
Johnson and Johnson
Colorcon
Citi
Harvard Business School
Healthtrust
Fish and Richardson
Mallinckrodt

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