Tenofovir Disoproxil Fumarate

Product NDC

0093-7104

11-digit product format

000937104

Labeler code

0093

Product ID

0093-7104_4c5e00b3-b42b-435e-8b16-646a364e9991

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Tenofovir Disoproxil Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA091612

Marketing category

ANDA

Marketing start

2017-12-15

Marketing end

2019-11-30

Substance

TENOFOVIR DISOPROXIL FUMARATE

Active strength

300 mg/1

Pharmacologic classes

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

0000-00-00

Current FDA listing

Historical FDA.report record