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Serving 500+ biopharmaceutical companies globally:

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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090892

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NDA 090892 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, and Ivax Sub Teva Pharms, and is included in twenty-two NDAs. It is available from ten 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 suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for NDA: 090892

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

Pharmacology for NDA: 090892

Ingredient-typeNicotinic Acids

Suppliers and Packaging for NDA: 090892

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 090892 ANDA LUPIN LIMITED 57297-222 57297-222-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57297-222-01)
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL 090892 ANDA LUPIN LIMITED 57297-222 57297-222-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (57297-222-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Mar 20, 2014TE:ABRLD:No


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Colorcon
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Moodys

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