Orange Book product · Brand (NDA)
CLAFORAN
CEFOTAXIME SODIUM
At a glance
Dec 29, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1983
43 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFOTAXIME SODIUM
Strength
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
004
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.
