Truvada

Product NDC

35356-070

11-digit product format

353560070

Labeler code

35356

Product ID

35356-070_85533da6-7829-44c8-906a-d8c499cf0a2c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

emtricitabine and tenofovir disoproxil fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

NDA021752

Marketing category

NDA

Marketing start

2004-08-02

Marketing end

0000-00-00

Substance

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

200 mg/1; mg/1

Pharmacologic classes

Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record