Atripla

Product NDC

70518-0341

11-digit product format

705180341

Labeler code

70518

Product ID

70518-0341_e15694cd-e146-494a-e053-2a95a90ab52d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

efavirenz, emtricitabine, and tenofovir disoproxil fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA021937

Marketing category

NDA

Marketing start

2017-03-20

Marketing end

0000-00-00

Substance

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

600 mg/1; mg/1; mg/1

Pharmacologic classes

Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]

NDC exclude flag

No

Listing certified through

2023-12-31

Current FDA listing

Historical FDA.report record