Application Nr Approved Date Route Status External Links
ANDA091294 2012-06-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Abacavir Tablets, In Combination With Other Antiretroviral Agents, Are Indicated For The Treatment Of Human Immunodeficiency Virus (hiv-1) Infection. Additional Important Information On The Use Of Abacavir Tablets For Treatment Of Hiv-1 Infection: Abacavir Tablets Are One Of Multiple Products Containing Abacavir. Before Starting Abacavir Tablets, Review Medical History For Prior Exposure To Any Abacavir-Containing Product In Order To Avoid Reintroduction In A Patient With A History Of Hypersensitivity To Abacavir [see Warnings And Precautions (5.1), Adverse Reactions (6)]. Abacavir, A Nucleoside Analogue, Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection. (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Abacavir Sulfate ABACAVIR SULFATE ZINC2015928