FDA Approval Activities for this Drug…

Droxia (hydroxyurea) Capsules, USP) Bristol-Myers Squibb Company NDA 16-295/S-036 HYDREA and DROXIA (hydroxyurea capsules, USP) Bristol-Myers Squibb Company ANDA 16-295/S-034 Hydroxyurea Capsules USP, 500 mg, Barr ANDA 75-143 10/16/98 10/20/98 9/25/02 Hydroxyurea Capsules USP, 500 mg, Duramed ANDA 75-020 7/30/98 8/5/98 9/25/02 Hydroxyurea Capsules USP, 500 mg, Par ANDA 75-340 2/24/99 3/4/99 Hydroxyurea Tablets USP, 1000 mg, Barr ANDA 75-734 HYDROXYUREA Capsule; 250MG HYDROXYUREA Barr 075143 HYDROXYUREA Capsule; 500MG HYDROXYUREA Barr 016295 HYDROXYUREA Capsule; 200MG DROXIA BRISTOL MYERS SQUIBB 016295 HYDROXYUREA Capsule; 300MG DROXIA BRISTOL MYERS SQUIBB 016295 HYDROXYUREA Capsule; 400MG DROXIA BRISTOL MYERS SQUIBB 016295 HYDROXYUREA Capsule; 500MG HYDREA BRISTOL MYERS SQUIBB 075020 HYDROXYUREA Capsule; 250MG HYDROXYUREA DURAMED Barr 075020 HYDROXYUREA Capsule; 500MG HYDROXYUREA DURAMED Barr 075340 HYDROXYUREA Capsule; 500MG HYDROXYUREA Par 074476 HYDROXYUREA Capsule; 500MG HYDROXYUREA Roxane 075734 HYDROXYUREA Tablet; 1GM HYDROXYUREA Barr HYDREA (hydroxyurea) Capsules, Bristol-Myers Squibb Company

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