Orange Book product · Brand (NDA)
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
CEFOTETAN DISODIUM
At a glance
Aug 09, 2007
Approved
Brand (NDA)
Application
Not listed
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
Not listed
Application
NDA 065430
Product number
001
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.
- 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 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.
