Tybost
These highlights do not include all the information needed to use TYBOST safely and effectively. See full prescribing information for TYBOST. TYBOST (cobicistat) tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
3784c35c-e87f-410c-900b-8fd6313c6010
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2021
Manufacturers
FDA
Gilead Sciences, Inc.
DUNS: 185049848
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COBICISTAT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1401
Application NumberNDA203094
Product Classification
M
Marketing Category
C73594
G
Generic Name
COBICISTAT
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2021
FDA Product Classification
INGREDIENTS (11)
COBICISTATActive
Quantity: 150 mg in 1 1
Code: LW2E03M5PG
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT