FDA Approval Activities for this Drug…

Niacin Extended-Release Tablets, 500 & 750mg, Barr, ANDA 76-378 6/13/03 Niacin Extended-Release Tablets, 1000mg, Barr, ANDA 76-250 5/9/03 Niacor (Niacin) Tablets USP, 500 mg, Upsher-Smith , ANDA 40-378 5/3/00 5/22/00 8/4/03 Niaspan (niacin extended-release) Tablets, 500 mg, 750 mg, 1000 mg, Kos NDA 20-381/S-13 1/31/03 2/12/03 2/13/03 Niaspan (niacin extended-release tablets), Kos NDA 20-381/S-007 9/13/99 9/24/99 Niaspan (niacin extended-release tablets), Kos NDA 20-381/S-006 Advicor (Niacin Extended Release & Lovastatin) Tablets, Kos ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K Injection 2 IU/ML;40MG/ML;12UGM/ML;40 IU/ML;1UGM/ML;3MG/ML;120UGM/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML INFUVITE ADULT Sabex 2002 021559 ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K Iv (Infusion) 2 IU/ML;40MG/ML;12UGM/ML;40 IU/ML;1UGM/ML;3MG/ML;120UGM/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30UGM/ML INFUVITE ADULT Sabex 2002 021265 ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K Iv (Infusion) 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL INFUVITE PEDIATRIC Sabex 2002 018920 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E For Solution; Iv (Infusion) 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL M.V.I. PEDIATRIC AAIPHARMA 008809 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E Injection 10MG/ML;0.006MG/ML;0.5UGM/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML M.V.I.-12 AAIPHARMA 021249 LOVASTATIN; NIACIN Tablet, Extended Release; 20MG;1GM ADVICOR KOS 021249 LOVASTATIN; NIACIN Tablet, Extended Release; 20MG;500MG ADVICOR KOS 021249 LOVASTATIN; NIACIN Tablet, Extended Release; 20MG;750MG ADVICOR KOS 020381 NIACIN Tablet, Extended Release; 1GM NIASPAN KOS 020381 NIACIN Tablet, Extended Release; 500MG NIASPAN KOS 020381 NIACIN Tablet, Extended Release; 750MG NIASPAN KOS 083823 NIACIN Tablet; 500MG NICOLAR AVENTIS 083525 NIACIN Tablet; 500MG NIACIN MK 084237 NIACIN Tablet; 500MG NIACIN TABLICAPS 040378 NIACIN Tablet; 500MG NIACOR Upsher Smith 081134 NIACIN Tablet; 500MG NIACIN Wockhardt | Niacin Extended-Release Tablet, Barr Laboratories, Approval | Niacin Extended-Release Tablets, Barr Labs, Approval

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