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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Citi
Baxter
Colorcon
US Department of Justice
Merck
Chinese Patent Office
Cerilliant
Accenture
Johnson and Johnson

Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076378

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NDA 076378 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: 076378

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

Pharmacology for NDA: 076378

Ingredient-typeNicotinic Acids

Suppliers and Packaging for NDA: 076378

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 076378 ANDA Teva Pharmaceuticals USA Inc 0093-7392 0093-7392-86 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0093-7392-86)
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 076378 ANDA Teva Pharmaceuticals USA Inc 0093-7392 0093-7392-98 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0093-7392-98)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 26, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Apr 26, 2005TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Queensland Health
Cerilliant
McKinsey
Fuji
Argus Health
QuintilesIMS
Healthtrust
Baxter
Mallinckrodt

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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