Tivicay
These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY.TIVICAY (dolutegravir tablets), for oral useInitial U.S. Approval: 2013
Approved
Approval ID
807b0cd2-093c-4353-a4a5-2e1f264616ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2019
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dolutegravir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1130
Application NumberNDA204790
Product Classification
M
Marketing Category
C73594
G
Generic Name
dolutegravir sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2019
FDA Product Classification
INGREDIENTS (11)
DOLUTEGRAVIR SODIUMActive
Quantity: 50 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT