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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Novartis
Colorcon
Chubb
Julphar
Fish and Richardson
AstraZeneca
Johnson and Johnson
Express Scripts

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090860

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NDA 090860 describes NIACIN, which is a drug marketed by Everylife, Watson Labs, Sandoz, Impax Labs, Hikma Pharms, 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 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 090860

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

Pharmacology for NDA: 090860

Ingredient-typeNicotinic Acids

Medical Subject Heading (MeSH) Categories for 090860

Suppliers and Packaging for NDA: 090860

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 090860 ANDA LUPIN LIMITED 57297-221 57297-221-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57297-221-01)
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 090860 ANDA LUPIN LIMITED 57297-221 57297-221-03 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (57297-221-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Mar 20, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Merck
Colorcon
Julphar
Chinese Patent Office
Chubb
Daiichi Sankyo
Fish and Richardson
Teva

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.

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