Orange Book product · Generic (ANDA)
OXALIPLATIN
OXALIPLATIN
At a glance
Jun 07, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 07, 2016
10 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
OXALIPLATIN
Strength
200MG/40ML (5MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 204368
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of OXALIPLATIN
- 2009OXALIPLATINBrand (NDA)
NDA 022160 · TEVA PHARMS
- 2005ELOXATINBrand (NDA)
NDA 021759 · SANOFI AVENTIS US
- 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
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.
