etravirine tablet 25 mg
1 INDICATIONS AND USAGE Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 6 years of age and older [see Microbiology (12.4) and Clinical Studies (14) ] . Additional pediatric use information is approved for Janssen Products, LP’s INTELENCE ® (etravirine) tablets. However, due to Janssen Products, LP’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older. (1)
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OVAL WHITE A56
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16 HOW SUPPLIED/STORAGE AND HANDLING
ETRAVIRINE Tablets, 25 mg are supplied as white to off-white, oval shaped, uncoated tablets containing 25 mg of
ETRAVIRINE. Each tablet is debossed with “A56” on one side and score on the other side. They are available as follows: Bottles of 120 with child-resistant closure: NDC 60219-1720-7 Each bottle contains 2 desiccant pouches.
ETRAVIRINE Tablets, 100 mg are supplied as white to off-white, oval shaped, uncoated tablets containing 100 mg of
ETRAVIRINE. Each tablet is debossed with “AC75” on one side and plain on the other side. They are available as follows: Bottles of 120 with child-resistant closure: NDC 60219-1721-7 Each bottle contains 3 desiccant pouches.
ETRAVIRINE Tablets, 200 mg are supplied as white to off-white, oval shaped, uncoated tablets containing 200 mg of
ETRAVIRINE. Each tablet is debossed with “AC76” on one side and plain on the other side. They are available as follows: Bottles of 60 with child-resistant closure: NDC 60219-1722-6 Each bottle contains 3 desiccant pouches. Store
ETRAVIRINE tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.
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