Orange Book product · Brand (NDA)
ELOXATIN
OXALIPLATIN
At a glance
Jan 31, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2005
21 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
OXALIPLATIN
Strength
50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 021759
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.
- 2009OXALIPLATINBrand (NDA)
NDA 022160 · TEVA PHARMS
- 2002ELOXATINBrand (NDA)
NDA 021492 · SANOFI AVENTIS US
- 2026OXALIPLATINGeneric (ANDA)
ANDA 219765 · SHANDONG
- 2025OXALIPLATINGeneric (ANDA)
ANDA 217925 · HETERO LABS LTD VI
- 2024OXALIPLATINGeneric (ANDA)
ANDA 217348 · MEITHEAL
- 2018OXALIPLATINGeneric (ANDA)
ANDA 207562 · INGENUS PHARMS LLC
- 2018OXALIPLATINGeneric (ANDA)
ANDA 204880 · ACTAVIS
- 2017OXALIPLATINGeneric (ANDA)
ANDA 205529 · EUGIA PHARMA
- 2017OXALIPLATINGeneric (ANDA)
ANDA 207385 · GLAND
- 2017OXALIPLATINGeneric (ANDA)
ANDA 204378 · AM REGENT
- 2017OXALIPLATINGeneric (ANDA)
ANDA 207474 · ACCORD HLTHCARE
- 2017OXALIPLATINGeneric (ANDA)
ANDA 208523 · CHARTWELL MOLECULAR
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.
