Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Hydrea and Droxia (hydroxyurea) Capsules, Bristol-Myers Squibb Co., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com