Product Details
Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablets**
Dolutegravir (Dolutegravir Sodium); Lamivudine; Tenofovir Disoproxil Fumarate50 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