Orange Book product · Generic (ANDA)
CEFOTETAN
CEFOTETAN DISODIUM
At a glance
Aug 09, 2007
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 09, 2007
19 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFOTETAN DISODIUM
Strength
EQ 1GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 065374
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 2011CEFOTETANGeneric (ANDA)
ANDA 091030 · WEST-WARD PHARM CORP
- 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.
