*** Disclaimer: This Database is still undergoing update on daily basis to prevent errors, discrepancies, and missing records. Please Contact FDIC@nafdac.gov.ng for enquires ***

Product Details

Hydroxyurea 1000mg Film Coated Tablets

Hydroxycarbamide
1000 mg
Film coated tablet

ROA

Oral

Applicant Name

Novartis Nigeria Limited

NRN

A4-100408

Status

Active


ATC Code

L01XX05  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 X 30  

Product Description

110 NF-PP-292503 110 NF-PP-292503 Hydroxyurea 1000mg Film Coated Tablets Hydroxycarbamide Hydroxycarbamide 1000mg; Silicified Microcrystalline Cellulose (e.g. Prosolv SMCC 90) 437.50mg; Sucralose 50.00mg; Orange Flavour 769467 5.00mg; Sodium stearyl fumarate 7.50mg; Opadry II 85F18422 50.00mg; Purified water Drugs Imported Products 1*30 POM 2 2/1/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS 2.34707E+12 arit.onwusah@novartis.com Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378, 93055 Regensburg, Germany, Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378, 93055 Regensburg, Germany, Germany Hydroxycarbamide Hydroxycarbamide 1000mg; Silicified Microcrystalline Cellulose (e.g. Prosolv SMCC 90) 437.50mg; Sucralose 50.00mg; Orange Flavour 769467 5.00mg; Sodium stearyl fumarate 7.50mg; Opadry II 85F18422 50.00mg; Purified water Drugs Imported Products 1*30 POM 2 2/1/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS 2.34707E+12 arit.onwusah@novartis.com Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378, 93055 Regensburg, Germany, Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378, 93055 Regensburg, Germany, Germany

Manufacturer Name

Haupt Pharma Amareg GmbH

Manufacturer Country

GERMANY  

Approval Date

2023-05-25  

Expiry Date

2028-05-24