COMPLERA

Product NDC

70518-0677

11-digit product format

705180677

Labeler code

70518

Product ID

70518-0677_c72f2363-1f66-cecd-e053-2a95a90ae524

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA202123

Marketing category

NDA

Marketing start

2017-08-16

Marketing end

0000-00-00

Substance

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

200 mg/1; mg/1; mg/1

Pharmacologic classes

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],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 flag

No

Listing certified through

2022-12-31

Current FDA listing

Historical FDA.report record