Genvoya

Product NDC

70518-0568

11-digit product format

705180568

Labeler code

70518

Product ID

70518-0568_d83766b4-2e3d-14d3-e053-2a95a90a80db

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Dosage form

TABLET

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA207561

Marketing category

NDA

Marketing start

2017-06-06

Marketing end

0000-00-00

Substance

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Active strength

150 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], HIV Integrase Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2023-12-31

Current FDA listing

Historical FDA.report record