*** 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

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 AND 300MG

Emtricitabine; Tenofovir Disoproxil Fumarate
200 mg; 300 mg
Tablet

ROA

Oral

Applicant Name

Onifam Laboratories Limited

NRN

A4-100333

Status

Active


ATC Code

J05AR03  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

 

Product Description

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 AND 300MG A4-100333 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 AND 300MG Each tablet contains 200 mg Emtricitabine and 300 mg Tenofovir Disoproxil Fumarate (TDF) equivalent to 245 mg of tenofovir disoproxil or 136 mg of tenofovir. List of Excipients Core tablet: Microcrystalline cellulose Lactose monohydrate Pregelatinized starch Croscarmellose sodium Magnesium stearate Film coat: Hydroxypropyl methylcellulose Lactose monohydrate Titanium dioxide Triacetin FD&C Blue #2/Indigo carmine aluminium lake POM 2 ONIFAM LABORATORIES LIMITED, IDIMU ROAD, ORELOPE EGBEDA, LAGOS. EGBEDA LAGOS Lupin Limited, Plot No.6A1, 6A2, sector-17, Economic Zone, Mihan, Nagpur, Maharashtra -144108, India, India 2/23/2023 2/22/2028

Manufacturer Name

Lupin Limited

Manufacturer Country

INDIA  

Approval Date

2023-02-23  

Expiry Date

2028-02-22