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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203578


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NDA 203578 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Eywa, Jubilant Generics, Lannett Co Inc, Lupin Ltd, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in thirty NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 203578
Tradename:NIACIN
Applicant:Amneal Pharms
Ingredient:niacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203578
Medical Subject Heading (MeSH) Categories for 203578
Suppliers and Packaging for NDA: 203578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578 ANDA AvPAK 50268-584 50268-584-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11)
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578 ANDA Amneal Pharmaceuticals LLC 65162-321 65162-321-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 24, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Jul 24, 2015TE:ABRLD:No

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