NDC 70518-3080

Biktarvy

Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate

Biktarvy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.

Product ID70518-3080_c109cddc-e382-3c5c-e053-2a95a90a455a
NDC70518-3080
Product TypeHuman Prescription Drug
Proprietary NameBiktarvy
Generic NameBictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-04-28
Marketing CategoryNDA /
Application NumberNDA210251
Labeler NameREMEDYREPACK INC.
Substance NameBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active Ingredient Strength50 mg/1; mg/1; mg/1
Pharm ClassesHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70518-3080-0

3 TABLET in 1 BLISTER PACK (70518-3080-0)
Marketing Start Date2021-04-28
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Biktarvy" or generic name "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate"

NDCBrand NameGeneric Name
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
70518-3080Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate

Trademark Results [Biktarvy]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIKTARVY
BIKTARVY
87226465 5344455 Live/Registered
Gilead Sciences Ireland UC
2016-11-04

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.