WHO Product ID
ANDA 217830 USFDA
Status
Prequalified
INN, dosage form and strength
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60 mg/5 mg/30 mg,
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablets for Oral Suspension
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1. 180x1
Shelf life (months)
24
FPP Manufacturing Site(s)
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India