Last Updated: November 9, 2026

Details for New Drug Application (NDA): 209236

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NDA 209236 describes NIACIN, which is a drug marketed by Adaptis, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Jubilant Generics, Macleods Pharms, Mpp Pharma, Quagen, Rising, Sun Pharm, Yichang Humanwell, Zydus Pharms, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in thirty-two NDAs. It is available from nine suppliers. Additional details are available on the NIACIN profile page.

The generic ingredient in NIACIN is niacin. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 209236
Tradename:NIACIN
Applicant:Aurobindo Pharma Ltd
Ingredient:niacin
Patents:0
Pharmacology for NDA: 209236
Medical Subject Heading (MeSH) Categories for 209236
Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex
Suppliers and Packaging for NDA: 209236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 209236 ANDA Aurobindo Pharma Limited 59651-018 59651-018-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-05)
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 209236 ANDA Aurobindo Pharma Limited 59651-018 59651-018-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Feb 1, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Feb 1, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Feb 1, 2018TE:ABRLD:No

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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