ABACAVIR , LAMIVUDINE AND ZIDOVUDINE
Drug Details
- Generic Name
- ABACAVIR , LAMIVUDINE AND ZIDOVUDINE
- Brand Names
- ABACAVIR, LAMIVUDINE AND ZIDOVUDINE
- Application Number
- ANDA202912
- Sponsor
- Lupin Pharmaceuticals, Inc.
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ABACAVIR SULFATE, LAMIVUDINE, ZIDOVUDINE
Indications and Usage
1 INDICATIONS AND USAGE Abacavir, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.( 1 ) Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: Limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see CLINICAL STUDIES ( 14 )] .