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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
For the most up-to-date approval information, please locate this API using the drug index.
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