FDA Orange Book · active-ingredient family
Cefadroxil/cefadroxil hemihydrate
Cefadroxil/cefadroxil hemihydrate is approved as 3 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DURICEF · NDA 050512
3
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DURICEFRLD×2 | WARNER CHILCOTT | NDA 050512 | — | Approved Prior to Jan 1, 1982 | |
| DURICEFRLD×3 | WARNER CHILCOTT | NDA 050527 | — | Approved Prior to Jan 1, 1982 | |
| DURICEFRLD | WARNER CHILCOTT | NDA 050528 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFADROXIL | CSPC OUYI | ANDA 205072 | — | Jul 28, 2017 | |
| CEFADROXIL×2 | AUROBINDO | ANDA 065349 | AB | Apr 25, 2013 | |
| CEFADROXIL×2 | HIKMA PHARMS | ANDA 091036 | — | Nov 28, 2012 | |
| CEFADROXIL×2 | LUPIN | ANDA 065396 | AB | Feb 21, 2008 | |
| CEFADROXIL | LUPIN | ANDA 065392 | AB | May 29, 2007 | |
| CEFADROXIL | AUROBINDO PHARMA | ANDA 065352 | AB | Jan 25, 2007 | |
| CEFADROXIL×2 | CHARTWELL RX | ANDA 065307 | — | Oct 16, 2006 | |
| CEFADROXIL | CHARTWELL RX | ANDA 065309 | — | Sep 18, 2006 | |
| CEFADROXIL | CHARTWELL RX | ANDA 065301 | — | Sep 18, 2006 | |
| CEFADROXIL | HIKMA | ANDA 065260 | — | Mar 30, 2006 | |
| CEFADROXIL | HIKMA | ANDA 065311 | — | Feb 07, 2006 | |
| CEFADROXIL | TEVA PHARMS | ANDA 065282 | AB | Jan 20, 2006 | |
| CEFADROXIL×2 | ANI PHARMS | ANDA 065278 | — | Jan 20, 2006 | |
| CEFADROXIL×3 | SUN PHARM INDS LTD | ANDA 065115 | — | Mar 26, 2003 | |
| CEFADROXIL | RANBAXY LABS LTD | ANDA 065015 | — | Jun 22, 1999 | |
| CEFADROXIL | RANBAXY | ANDA 065018 | — | Apr 23, 1999 | |
| CEFADROXIL×3 | ANI PHARMS | ANDA 062698 | — | Mar 01, 1989 | |
| CEFADROXIL | TEVA | ANDA 062695 | — | Feb 10, 1989 | |
| CEFADROXIL | PUREPAC PHARM | ANDA 063017 | — | Jan 05, 1989 | |
| CEFADROXIL | TEVA PHARMS | ANDA 062774 | — | Apr 08, 1987 | |
| CEFADROXIL | IVAX SUB TEVA PHARMS | ANDA 062766 | — | Mar 03, 1987 | |
| ULTRACEF | BRISTOL | ANDA 062408 | — | Aug 31, 1982 | |
| ULTRACEF | APOTHECON | ANDA 062390 | — | Jun 10, 1982 | |
| ULTRACEF | BRISTOL | ANDA 062378 | — | Mar 16, 1982 | |
| ULTRACEF×3 | BRISTOL | ANDA 062376 | — | Mar 16, 1982 | |
| CEFADROXIL | SANDOZ | ANDA 062291 | — | Approved Prior to Jan 1, 1982 | |
| CEFADROXIL×3 | APOTHECON | ANDA 062334 | — | 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.
Cefadroxil/cefadroxil hemihydrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
