Orange Book product · Generic (ANDA)
CEFADROXIL
CEFADROXIL/CEFADROXIL HEMIHYDRATE
At a glance
Apr 08, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 1987
39 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Strength
EQ 1GM BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 062774
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of CEFADROXIL/CEFADROXIL HEMIHYDRATE
- —DURICEFBrand (NDA)
NDA 050512 · WARNER CHILCOTT
- —DURICEFBrand (NDA)
NDA 050527 · WARNER CHILCOTT
- —DURICEFBrand (NDA)
NDA 050528 · 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
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.
