FDA Orange Book · active-ingredient family
Cefuroxime axetil
Cefuroxime axetil is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFTIN · NDA 050672
2
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFTINRLD×2 | GLAXOSMITHKLINE | NDA 050672 | — | Jun 30, 1994 | |
| CEFTINRLD×3 | GLAXOSMITHKLINE | NDA 050605 | — | Dec 28, 1987 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFUROXIME AXETIL×2 | ALKEM LABS LTD | ANDA 065496 | AB | Jun 07, 2010 | |
| CEFUROXIME AXETIL×3 | ANDA REPOSITORY | ANDA 065359 | AB | Feb 15, 2008 | |
| CEFUROXIME AXETIL×2 | SUN PHARM INDS LTD | ANDA 065323 | — | Feb 05, 2008 | |
| CEFUROXIME AXETIL×3 | AUROBINDO PHARMA | ANDA 065308 | AB | Mar 29, 2006 | |
| CEFUROXIME AXETIL×3 | CHARTWELL RX | ANDA 065166 | AB | Jul 29, 2005 | |
| CEFUROXIME AXETIL×2 | ANI PHARMS | ANDA 065190 | — | Oct 18, 2004 | |
| CEFUROXIME AXETIL×2 | FOSUN PHARMA | ANDA 065126 | — | Oct 28, 2003 | |
| CEFUROXIME AXETIL×2 | LUPIN | ANDA 065135 | — | Jul 25, 2003 | |
| CEFUROXIME AXETIL×3 | SUN PHARM INDS LTD | ANDA 065118 | — | Apr 25, 2003 | |
| CEFUROXIME AXETIL×2 | APOTEX | ANDA 065069 | — | Oct 02, 2002 | |
| CEFUROXIME AXETIL×3 | RANBAXY LABS LTD | ANDA 065043 | — | Feb 15, 2002 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Cefuroxime axetil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
