FDA Orange Book · active-ingredient family
Ceftriaxone sodium
Ceftriaxone sodium is approved as 3 brand and 39 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER · NDA 050796
3
Brand (NDA)
39
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERRLD×2 | B BRAUN | NDA 050796 | AP | Apr 20, 2005 | |
| ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERRLD×3 | HOFFMANN LA ROCHE | NDA 050624 | — | Feb 11, 1987 | |
| ROCEPHINRLD×5 | HOFFMANN LA ROCHE | NDA 050585 | — | Dec 21, 1984 |
Generic (ANDA) products (39)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFTRIAXONE×4 | DEVA HOLDING AS | ANDA 210197 | — | Jan 12, 2024 | |
| CEFTRIAXONE | QILU ANTIBIOTICS | ANDA 209218 | AP | Oct 17, 2018 | |
| CEFTRIAXONE×4 | ASTRAL | ANDA 091049 | — | Jun 11, 2018 | |
| CEFTRIAXONE SODIUM | HIKMA | ANDA 090701 | AP | Oct 04, 2017 | |
| CEFTRIAXONE SODIUM | ANDA REPOSITORY | ANDA 091117 | AP | Jan 20, 2017 | |
| CEFTRIAXONE×4 | QILU ANTIBIOTICS | ANDA 203702 | AP | Jun 29, 2016 | |
| CEFTRIAXONE | SAMSON MEDCL | ANDA 090057 | — | Apr 25, 2014 | |
| CEFTRIAXONE | AGILA SPECLTS | ANDA 091068 | — | Jan 07, 2013 | |
| CEFTRIAXONE×2 | HOSPIRA INC | ANDA 202563 | — | Aug 20, 2012 | |
| CEFTRIAXONE | BEDFORD | ANDA 065475 | — | Aug 18, 2008 | |
| CEFTRIAXONE×4 | BEDFORD | ANDA 065465 | — | Aug 18, 2008 | |
| CEFTRIAXONE | AUROBINDO PHARMA LTD | ANDA 065504 | — | Jul 31, 2008 | |
| CEFTRIAXONE×4 | AUROBINDO PHARMA LTD | ANDA 065505 | — | Jul 31, 2008 | |
| CEFTRIAXONE×3 | ACS DOBFAR | ANDA 065329 | AP | Jul 24, 2008 | |
| CEFTRIAXONE | ACS DOBFAR | ANDA 065328 | AP | Jul 24, 2008 | |
| CEFTRIAXONE×4 | EPIC PHARMA LLC | ANDA 065305 | AP | Jan 11, 2008 | |
| CEFTRIAXONE×4 | HIKMA FARMACEUTICA | ANDA 065342 | AP | Jan 10, 2008 | |
| CEFTRIAXONE×3 | WOCKHARDT BIO AG | ANDA 065391 | AP | Apr 12, 2007 | |
| CEFTRIAXONE×4 | CEPHAZONE PHARMA | ANDA 065294 | — | Mar 26, 2007 | |
| CEFTRIAXONE×4 | TEVA PHARMS USA | ANDA 065227 | — | Mar 15, 2007 | |
| CEFTRIAXONE | FACTA FARMA | ANDA 065269 | — | Feb 28, 2007 | |
| CEFTRIAXONE×2 | FACTA FARMA | ANDA 065268 | — | Feb 28, 2007 | |
| CEFTRIAXONE | LUPIN | ANDA 065263 | — | Sep 12, 2006 | |
| CEFTRIAXONE×2 | TEVA | ANDA 065262 | — | Jun 29, 2006 | |
| CEFTRIAXONE | APOTEX | ANDA 065180 | AP | May 12, 2006 | |
| CEFTRIAXONE | TEVA | ANDA 065274 | — | May 01, 2006 | |
| CEFTRIAXONE | FRESENIUS KABI USA | ANDA 065252 | — | Feb 15, 2006 | |
| CEFTRIAXONE×4 | FRESENIUS KABI USA | ANDA 065245 | — | Feb 15, 2006 | |
| CEFTRIAXONE IN PLASTIC CONTAINER×2 | BAXTER HLTHCARE | ANDA 065224 | — | Aug 23, 2005 | |
| CEFTRIAXONE×2 | HOSPIRA INC | ANDA 065231 | — | Aug 02, 2005 | |
| CEFTRIAXONE | HOSPIRA INC | ANDA 065232 | — | Aug 02, 2005 | |
| CEFTRIAXONE×4 | HOSPIRA INC | ANDA 065230 | — | Aug 02, 2005 | |
| CEFTRIAXONE | SANDOZ | ANDA 065168 | AP | May 17, 2005 | |
| CEFTRIAXONE×4 | SANDOZ | ANDA 065169 | AP | May 09, 2005 | |
| CEFTRIAXONE×2 | SANDOZ INC | ANDA 065204 | — | May 03, 2005 | |
| CEFTRIAXONE×4 | LUPIN | ANDA 065125 | — | Sep 30, 2003 | |
| ROCEPHIN×3 | HOFFMANN LA ROCHE | ANDA 063239 | — | Aug 13, 1993 | |
| ROCEPHIN×3 | HOFFMANN LA ROCHE | ANDA 062654 | — | Apr 30, 1987 | |
| ROCEPHIN×3 | ROCHE | ANDA 062510 | — | Mar 12, 1985 |
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.
Ceftriaxone sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
