Orange Book product · Brand (NDA)
CLAFORAN
CEFOTAXIME SODIUM
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
CEFOTAXIME SODIUM
Strength
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050547
Product number
003
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.
- 2004CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINERBrand (NDA)
NDA 050792 · B BRAUN
- 1985CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 050596 · STERIMAX
- 2016CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 203132 · HOSPIRA
- 2010CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065348 · CEPHAZONE PHARMA
- 2009CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065517 · AUROBINDO PHARMA
- 2009CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065516 · AUROBINDO PHARMA LTD
- 2006CEFOTAXIMEGeneric (ANDA)
ANDA 065197 · WOCKHARDT
- 2006CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065290 · HOSPIRA INC
- 2006CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065293 · HOSPIRA INC
- 2006CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065292 · HOSPIRA INC
- 2003CEFOTAXIME SODIUMGeneric (ANDA)
ANDA 065124 · LUPIN
- 2002CEFOTAXIMEGeneric (ANDA)
ANDA 065072 · 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.
