BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Novartis
Fuji
Accenture
Citi
Cantor Fitzgerald
Baxter
Farmers Insurance
Boehringer Ingelheim
Queensland Health
Mallinckrodt

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200484

« Back to Dashboard

NDA 200484 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 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. Twenty-two 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 47335-539-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-88)
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)

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Harvard Business School
Express Scripts
Mallinckrodt
Fuji
Moodys
Julphar
Citi
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot