TENOFOVIR DISOPROXIL FUMARATE Tablets
Drug Details
- Generic Name
- TENOFOVIR DISOPROXIL FUMARATE Tablets
- Brand Names
- TENOFOVIR DISOPROXIL FUMARATE
- Application Number
- ANDA206481
- Sponsor
- Chartwell RX, LLC.
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- TENOFOVIR DISOPROXIL FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 kg.