FDA Orange Book · active-ingredient family
Cefaclor
Cefaclor is approved as 3 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CECLOR · NDA 050521
3
Brand (NDA)
30
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, tablet, chewable, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CECLORRLD×2 | LILLY | NDA 050521 | — | Approved Prior to Jan 1, 1982 | |
| CECLORRLD×2 | LILLY | NDA 050522 | — | Approved Prior to Jan 1, 1982 | |
| CECLOR CD×2 | LILLY | NDA 050673 | — | Jun 28, 1996 |
Generic (ANDA) products (30)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFACLOR×4 | YUNG SHIN PHARM | ANDA 065412 | — | Feb 17, 2012 | |
| CEFACLOR×2 | HIKMA | ANDA 065350 | — | Apr 03, 2007 | |
| CEFACLOR×2 | YUNG SHIN PHARM | ANDA 065146 | — | Jan 22, 2004 | |
| RANICLOR×4 | RANBAXY LABS LTD | ANDA 065092 | — | Dec 22, 2003 | |
| CEFACLOR×2 | TEVA | ANDA 065058 | — | Sep 04, 2002 | |
| CEFACLOR | WORLD GEN | ANDA 065057 | — | Jan 05, 2001 | |
| CEFACLOR | WATSON LABS INC | ANDA 064204 | — | Feb 18, 1998 | |
| CEFACLOR | WATSON LABS INC | ANDA 064205 | — | Feb 18, 1998 | |
| CEFACLOR | WATSON LABS INC | ANDA 064206 | — | Feb 18, 1998 | |
| CEFACLOR | WATSON LABS INC | ANDA 064207 | — | Feb 18, 1998 | |
| CEFACLOR | RANBAXY | ANDA 064166 | — | Oct 02, 1997 | |
| CEFACLOR | RANBAXY | ANDA 064165 | — | Oct 02, 1997 | |
| CEFACLOR | RANBAXY | ANDA 064164 | — | Oct 02, 1997 | |
| CEFACLOR | RANBAXY | ANDA 064155 | — | Oct 02, 1997 | |
| CEFACLOR×2 | RANBAXY | ANDA 064156 | — | Aug 28, 1997 | |
| CEFACLOR×2 | TEVA | ANDA 064081 | — | Sep 16, 1996 | |
| CEFACLOR×2 | TEVA | ANDA 064145 | — | Jun 24, 1996 | |
| CEFACLOR×2 | CHARTWELL RX | ANDA 064148 | — | May 23, 1996 | |
| CEFACLOR | DAVA PHARMS INC | ANDA 064114 | — | Apr 28, 1995 | |
| CEFACLOR | DAVA PHARMS INC | ANDA 064115 | — | Apr 28, 1995 | |
| CEFACLOR | DAVA PHARMS INC | ANDA 064116 | — | Apr 28, 1995 | |
| CEFACLOR | DAVA PHARMS INC | ANDA 064110 | — | Apr 28, 1995 | |
| CEFACLOR | IVAX SUB TEVA PHARMS | ANDA 064087 | — | Apr 28, 1995 | |
| CEFACLOR | IVAX SUB TEVA PHARMS | ANDA 064086 | — | Apr 28, 1995 | |
| CEFACLOR | IVAX SUB TEVA PHARMS | ANDA 064085 | — | Apr 28, 1995 | |
| CEFACLOR | IVAX SUB TEVA PHARMS | ANDA 064070 | — | Apr 28, 1995 | |
| CEFACLOR×2 | DAVA PHARMS INC | ANDA 064107 | — | Apr 27, 1995 | |
| CEFACLOR×2 | IVAX SUB TEVA PHARMS | ANDA 064061 | — | Apr 27, 1995 | |
| CEFACLOR×2 | CEPH INTL | ANDA 062205 | — | Approved Prior to Jan 1, 1982 | |
| CEFACLOR×4 | FACTA FARMA | ANDA 062206 | — | Approved Prior to Jan 1, 1982 |
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.
Cefaclor — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
