Orange Book product · Brand (NDA)
CECLOR
CEFACLOR
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
CEFACLOR
Strength
EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050522
Product number
002
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.
- 1996CECLOR CDBrand (NDA)
NDA 050673 · LILLY
- —CECLORBrand (NDA)
NDA 050521 · LILLY
- 2012CEFACLORGeneric (ANDA)
ANDA 065412 · YUNG SHIN PHARM
- 2007CEFACLORGeneric (ANDA)
ANDA 065350 · HIKMA
- 2004CEFACLORGeneric (ANDA)
ANDA 065146 · YUNG SHIN PHARM
- 2003RANICLORGeneric (ANDA)
ANDA 065092 · RANBAXY LABS LTD
- 2002CEFACLORGeneric (ANDA)
ANDA 065058 · TEVA
- 2001CEFACLORGeneric (ANDA)
ANDA 065057 · WORLD GEN
- 1998CEFACLORGeneric (ANDA)
ANDA 064204 · WATSON LABS INC
- 1998CEFACLORGeneric (ANDA)
ANDA 064205 · WATSON LABS INC
- 1998CEFACLORGeneric (ANDA)
ANDA 064206 · WATSON LABS INC
- 1998CEFACLORGeneric (ANDA)
ANDA 064207 · WATSON LABS INC
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.
