Orange Book product · Brand (NDA)
DURICEF
CEFADROXIL/CEFADROXIL HEMIHYDRATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Strength
EQ 1GM BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 050528
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —DURICEFBrand (NDA)
NDA 050512 · WARNER CHILCOTT
- —DURICEFBrand (NDA)
NDA 050527 · WARNER CHILCOTT
- 2017CEFADROXILGeneric (ANDA)
ANDA 205072 · CSPC OUYI
- 2013CEFADROXILGeneric (ANDA)
ANDA 065349 · AUROBINDO
- 2012CEFADROXILGeneric (ANDA)
ANDA 091036 · HIKMA PHARMS
- 2008CEFADROXILGeneric (ANDA)
ANDA 065396 · LUPIN
- 2007CEFADROXILGeneric (ANDA)
ANDA 065392 · LUPIN
- 2007CEFADROXILGeneric (ANDA)
ANDA 065352 · AUROBINDO PHARMA
- 2006CEFADROXILGeneric (ANDA)
ANDA 065307 · CHARTWELL RX
- 2006CEFADROXILGeneric (ANDA)
ANDA 065309 · CHARTWELL RX
- 2006CEFADROXILGeneric (ANDA)
ANDA 065301 · CHARTWELL RX
- 2006CEFADROXILGeneric (ANDA)
ANDA 065260 · HIKMA
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.
