emtricitabine 167 MG Tenofovir disoproxil fumarate 250 MG Oral Tablet
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ): Emtricitabine and tenofovir disoproxil fumarate tablet 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) ] .
Amneal Pharmaceuticals NY LLC
OVAL BLUE AC53
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emtricitabine and tenofovir disoproxil fumarate tablet film coated
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16 HOW SUPPLIED/STORAGE AND HANDLING Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 tablets with child-resistant closure as follows: Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg are supplied as blue, oval-shaped, film-coated tablet, debossed on one side with “AC51” and plain on the other side. Each tablet contains 100 mg of emtricitabine (FTC) and 150 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 123 mg of tenofovir disoproxil). They are available as follows: Bottles of 30: NDC 69238-1547-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 133 mg/200 mg are supplied as blue, modified capsule-shaped, film-coated tablet, debossed on one side with “AC52” and plain on the other side. Each tablet contains 133 mg of emtricitabine (FTC) and 200 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 163 mg of tenofovir disoproxil). They are available as follows: Bottles of 30: NDC 69238-1549-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 167 mg/250 mg are supplied as blue, modified capsule-shaped, film-coated tablet, debossed on one side with “AC53” and plain on the other side. Each tablet contains 167 mg of emtricitabine (FTC) and 250 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 204 mg of tenofovir disoproxil). They are available as follows: Bottles of 30: NDC 69238-1548-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg are supplied as blue, capsule-shaped, film-coated tablet, debossed on one side with “AC24” and plain on the other side. Each tablet contains 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 245 mg of tenofovir disoproxil). They are available as follows: Bottles of 30: NDC 69238-1527-3 Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Keep container tightly closed Dispense only in original container
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