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| FDA approval activities for this prescription drug:
Trizivir (abacavir sulfate, lamivudine, zidovudine) Tablets, GlaxoSmithKline NDA 21-205/S-007 10/8/02 10/11/01 10/8/02 Trizivir (abacavir sulfate, lamivudine, zidovudine) Tablets, GlaxoSmithKline NDA 21-205/S-006 8/13/02 8/21/02 8/14/02 Trizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoWellcome NDA 21-205/S-003 6/4/02 6/7/02 Trizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoSmithKline NDA 21-205/S-002 2/5/02 4/16/02 Trizivir (abacavir sulfate, lamivudine, zidovudine), Glaxo Wellcome NDA 21-205 11/14/00 6/17/02 Trizivir Indications: for the treatment of HIV-1 Infection Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S10 & NDA 20-978/S12 7/17/03 7/28/03 9/25/03 Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S8 & NDA 20-978/S10 8/14/02 8/21/02 8/14/02 Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S7 & NDA 20-978/S8 10/2/02 10/11/01 10/3/02 Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S5 & NDA 20-978/S6 1/28/02 3/6/02 Ziagen (abacavir sulfate) Tablets and Solution, Glaxo Wellcome NDA 20-977 & NDA 20-978 12/17/98 1/6/99 1/6/99 4/4/02 Ziagen Indications: For the treatment of HIV-1 infection in adults and children (ages 3 months and above). This indication is based on analyses of surrogate markers in controlled studies up to 24 weeks in duration. |
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