Orange Book product · Brand (NDA)
CECLOR CD
CEFACLOR
At a glance
Jun 28, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 1996
30 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFACLOR
Strength
EQ 375MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 050673
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —CECLORBrand (NDA)
NDA 050521 · LILLY
- —CECLORBrand (NDA)
NDA 050522 · 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.
