Product Details

Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablets**

Dolutegravir (Dolutegravir Sodium); Lamivudine; Tenofovir Disoproxil Fumarate
50 mg; 300 mg; 300 mg
Tablet

ROA

Oral

Applicant Name

Oxus Pharma Ltd

NRN

C4-1704

Status

Active


Composition

Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate 50 mg/300 mg/300 mg Tablets. Each tablet contains 50 mg Dolutegravir equivalent to 52.6 mg Dolutegravir sodium, 300 mg Lamivudine, and 300 mg Tenofovir disoproxil fumarate (TDF) equivalent to 245 mg of Tenofovir disoproxil or 136 mg of Tenofovir. Excipient with known effect: Each film-coated tablet contains about 15.4 mg (0.67 mmol) of Sodium and 120 mg of Mannitol.  

ATC Code

J05AR27  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 x 30's;1 x 90's (in HDPE bottles)  

Product Description

Film coated Tablets. White to off-white, capsule shaped, film coated tablet debossed with 'F67' on one side and plain on the other side

Manufacturer Name

Macleods Pharmaceuticals Ltd.

Manufacturer Country

INDIA  

Approval Date

2024-10-31  

Expiry Date

2029-10-30