Orange Book product · Brand (NDA)
CEFOTAN
CEFOTETAN DISODIUM
At a glance
Dec 27, 1985
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1985
41 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFOTETAN DISODIUM
Strength
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050588
Product number
001
Marketing status
RX
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.
- 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.
