tenofovir disoproxil fumarate
tenofovir disoproxil fumarate is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including tenofovir disoproxil fumarate, TENOFOVIR DISOPROXIL FUMARATE. Available dosage forms: tablet, film coated, tablet, coated, powder, tablet.
Drug Details
- Generic Name
- tenofovir disoproxil fumarate
- Brand Names
- tenofovir disoproxil fumarate, TENOFOVIR DISOPROXIL FUMARATE
- Application Number
- ANDA203232
- Sponsor
- Macleods Pharmaceuticals Limited
- NDC Codes
- 6
- Dosage Forms
- TABLET, FILM COATED, TABLET, COATED, POWDER, TABLET
- Routes
- ORAL
- Active Ingredients
- TENOFOVIR DISOPROXIL FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ) Emtricitabine and tenofovir disoproxil fumarate tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP. 1.1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies ( 14 )] . 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 )].