Symtuza
These highlights do not include all the information needed to use SYMTUZA safely and effectively. See full prescribing information for SYMTUZA. SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
85a17d00-6b7c-41ea-a6b3-5ad924820dab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2023
Manufacturers
FDA
Janssen Products LP
DUNS: 804684207
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-800
Application NumberNDA210455
Product Classification
M
Marketing Category
C73594
G
Generic Name
Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (12)
DARUNAVIRActive
Quantity: 800 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
COBICISTATActive
Quantity: 150 mg in 1 1
Code: LW2E03M5PG
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TENOFOVIR ALAFENAMIDEActive
Quantity: 10 mg in 1 1
Code: EL9943AG5J
Classification: ACTIR
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 3/31/2023
RECENT MAJOR CHANGES
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Contraindications ( 4) |
04/2022 |