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FDA Approval Activities for this Drug…
Ceftin (cefuroxime axetil) Tablets, GlaxoSmithKline NDA 50-605/S-037 7/24/02 8/6/02 Ceftin (cefuroxime axetil) Tablets and Suspension, GlaxoSmithKline NDA 50-605/SE8-033; 50-672/SE8-018 4/11/02 4/16/02 4/15/02 Ceftin (cefuroxime axetil) Tablets and Suspension GlaxoWellcome NDA 50-605/SE8-032; 50-672/SE8-014 8/24/99 10/6/99 7/12/00 7/3/00 Ceftin (cefuroxime axetil) Tablets and Suspension, GlaxoSmithKline NDA 50-605/SE8-031; 50-672/SE8-013 Cefuroxime for Injection USP & Dextrose Injection USP, B. Braun Medical NDA 50-780/S5 8/18/03 08/29/03 Cefuroxime for Injection USP & Dextrose Injection USP, B. Braun Medical NDA 50-780 2/21/01 1/30/02 1/30/02 1/30/02 Cefuroxime Injection, 7.5 g (base)/vial Astra USA ANDA 64-191 4/13 5/6/98 Cefuroxime Injection, 750 mg (base) and 1.5 g (base) Astra USA ANDA 64-192 4/13 5/6/98 Cefuroxime Injection, 750 mg/10 mL, 1.5 g/20 mL, 750 mg/100 mL, & 1.5 g/100 mL, American Pharmaceutical Partners ANDA 65-001 5/30/01 6/5/01 Cefuroxime Injection, 7.5 g (Pharmacy Bulk Package), American Pharmaceutical Partners ANDA 65-002 9/28/98 9/28/98 9/27/02 Cefuroxime Axetil Tablets USP, 250 & 500 mg, Lupin Limited ANDA 65-135 7/25/03 Cefuroxime Axetil Tablets USP, 125, 250 & 500 mg, Ranbaxy ANDA 65-118 4/25/03 Cefuroxime Axetil Tablets USP, 125, 250 & 500 mg, Ranbaxy laboratories Limited ANDA 65-043 2/15/02 10/10/02 Cefuroxime Axetil Tablets USP, 250 & 500 mg, Apotex Corp. ANDA 65-069 Zinacef (Cefuroxime for Injection and Dextrose Injection) USP, B. Braun Medical NDA 50-780 2/21/01 Zinacef Indications: Lower respiratory tract infections, urinary tract infections, skin and skin structure infections, septicemia, meningitis, gonorrhea, and bone and joint infections (same as Zinacef). Zinacef (Cefuroxime for Injection) GlaxoSmithKline NDA 50-558/S-050 10/12/01 5/2/03 Zinacef (Cefuroxime for Injection) GlaxoSmithKline NDA 50-643/S- Cefuroxime Axetil Tablets USP, Biochemie CEFUROXIME AXETIL For Suspension; 125MG BASE/5ML CEFTIN GLAXOSMITHKLINE 050672 CEFUROXIME AXETIL For Suspension; 250MG BASE/5ML CEFTIN GLAXOSMITHKLINE 065069 CEFUROXIME AXETIL Tablet; 250MG BASE CEFUROXIME AXETIL Apotex 065069 CEFUROXIME AXETIL Tablet; 500MG BASE CEFUROXIME AXETIL Apotex 050605 CEFUROXIME AXETIL Tablet; 125MG BASE CEFTIN GLAXOSMITHKLINE 050605 CEFUROXIME AXETIL Tablet; 250MG BASE CEFTIN GLAXOSMITHKLINE 050605 CEFUROXIME AXETIL Tablet; 500MG BASE CEFTIN GLAXOSMITHKLINE 065135 CEFUROXIME AXETIL Tablet; 250MG BASE CEFUROXIME AXETIL Lupin 065135 CEFUROXIME AXETIL Tablet; 500MG BASE CEFUROXIME AXETIL Lupin 065043 CEFUROXIME AXETIL Tablet; 125MG BASE CEFUROXIME AXETIL Ranbaxy 065118 CEFUROXIME AXETIL Tablet; 125MG BASE CEFUROXIME AXETIL Ranbaxy 065118 CEFUROXIME AXETIL Tablet; 250MG BASE CEFUROXIME AXETIL Ranbaxy 065043 CEFUROXIME AXETIL Tablet; 250MG BASE CEFUROXIME AXETIL Ranbaxy 065043 CEFUROXIME AXETIL Tablet; 500MG BASE CEFUROXIME AXETIL Ranbaxy 065118 CEFUROXIME AXETIL Tablet; 500MG BASE CEFUROXIME AXETIL Ranbaxy 065001 CEFUROXIME SODIUM Im-Iv 750MG BASE/VIAL CEFUROXIME AM PARTNERS 050558 CEFUROXIME SODIUM Im-Iv 750MG BASE/VIAL ZINACEF GLAXOSMITHKLINE 064125 CEFUROXIME SODIUM Im-Iv 750MG BASE/VIAL CEFUROXIME SODIUM HANFORD GC 062591 CEFUROXIME SODIUM Im-Iv 750MG BASE/VIAL KEFUROX LILLY 064035 CEFUROXIME SODIUM Im-Iv 750MG BASE/VIAL CEFUROXIME SODIUM MARSAM 064192 CEFUROXIME SODIUM Im-Iv 750MG BASE/VIAL CEFUROXIME Teva 065001 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL CEFUROXIME AM PARTNERS 065002 CEFUROXIME SODIUM Injection 7.5GM BASE/VIAL CEFUROXIME SODIUM AM PARTNERS 050780 CEFUROXIME SODIUM Injection 15MG BASE/ML CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER B BRAUN 050780 CEFUROXIME SODIUM Injection 30MG BASE/ML CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER B BRAUN 050558 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL ZINACEF GLAXOSMITHKLINE 050643 CEFUROXIME SODIUM Injection 15MG BASE/ML ZINACEF IN PLASTIC CONTAINER GLAXOSMITHKLINE 050643 CEFUROXIME SODIUM Injection 30MG BASE/ML ZINACEF IN PLASTIC CONTAINER GLAXOSMITHKLINE 050558 CEFUROXIME SODIUM Injection 7.5GM BASE/VIAL ZINACEF GLAXOSMITHKLINE 064125 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL CEFUROXIME SODIUM HANFORD GC 064124 CEFUROXIME SODIUM Injection 7.5GM BASE/VIAL CEFUROXIME SODIUM HANFORD GC 062591 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL KEFUROX LILLY 062592 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL KEFUROX LILLY 062591 CEFUROXIME SODIUM Injection 7.5GM BASE/VIAL KEFUROX LILLY 064035 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL CEFUROXIME SODIUM MARSAM 064036 CEFUROXIME SODIUM Injection 7.5GM BASE/VIAL CEFUROXIME SODIUM MARSAM 064192 CEFUROXIME SODIUM Injection 1.5GM BASE/VIAL CEFUROXIME Teva | 064191 CEFUROXIME SODIUM Injection 7.5GM BASE/VIAL CEFUROXIME Teva | 062592 CEFUROXIME SODIUM Intravenous 750MG BASE/VIAL KEFUROX LILLY | Zinacef (cefuroxime for injection), Glaxo Group Limited | Zinacef (cefuroxime injection), Glaxo Group Limited | Ceftin (cefuroxime axetil) for Oral Suspension, GlaxoSmithKline | Ceftin (cefuroxime axetil) Tablets, GlaxoSmithKline Cefuroxime for Injection USP and Dextrose Injection USP, B. Braun Medical Inc., Labeling Revision | Cefuroxime Axetil Tablets, Teva Pharma, Approval | Cefuroxime Axetil Tablets, Wockhardt, Approval | Cefuroxime Axetil Tablets, Aurobindo Pharma, Approval | CEFTIN (cefuroxime axetil) Tablets, GlaxoSmithKline, Labeling Revision | CEFTIN (cefuroxime axetil) Oral Suspension, GlaxoSmithKline, Labeling Revision | Zinacef (cefuroxime) Injection, GlaxoSmithKline, Labeling Revision | Cefuroxime Axetil Oral Suspension, Ranbaxy, Approval | Cefuroxime Axetil Tablets, Orchid Healthcare, Approval | Cefuroxime Sodium Intramuscular I.V. Injection, Orchid Healthcare, Approval | Cefuroxime Sodium Intramuscular I.V. Injection, Orchid Healthcare, Approval
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