Orange Book product · Generic (ANDA)
CEFOTETAN
CEFOTETAN DISODIUM
At a glance
Oct 26, 2011
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 26, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFOTETAN DISODIUM
Strength
EQ 10GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 091030
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CEFOTETAN DISODIUM
- 2007CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 065430 · B BRAUN
- 1993CEFOTAN IN PLASTIC CONTAINERBrand (NDA)
NDA 050694 · PAI HOLDINGS PHARM
- 1985CEFOTANBrand (NDA)
NDA 050588 · PAI HOLDINGS PHARM
- 2011CEFOTETANGeneric (ANDA)
ANDA 091031 · HIKMA
- 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.
