Orange Book product · Brand (NDA)
CEFOTAN
CEFOTETAN DISODIUM
At a glance
Apr 25, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 1988
38 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFOTETAN DISODIUM
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EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050588
Product number
003
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.
- 2007CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 065430 · B BRAUN
- 1993CEFOTAN IN PLASTIC CONTAINERBrand (NDA)
NDA 050694 · PAI HOLDINGS PHARM
- 2011CEFOTETANGeneric (ANDA)
ANDA 091031 · HIKMA
- 2011CEFOTETANGeneric (ANDA)
ANDA 091030 · WEST-WARD PHARM CORP
- 2007CEFOTETANGeneric (ANDA)
ANDA 065374 · FRESENIUS KABI USA
- 2007CEFOTETANGeneric (ANDA)
ANDA 065375 · FRESENIUS KABI USA
- 1993CEFOTANGeneric (ANDA)
ANDA 063293 · TELIGENT
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.
