FDA.reportPublic FDA data

Application 078817

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS50MG/10ML (5MG/ML)NoNo
002OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS100MG/20ML (5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-3317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9315OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9317OxaliplatinOxaliplatinSandoz IncANDACurrent
0781-9317OxaliplatinOxaliplatinSandoz IncANDACurrent
43066-014OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-014OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-014OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-014OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-014OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-018OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-018OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-018OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-018OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
43066-018OxaliplatinOxaliplatinBaxter Healthcare CorporationANDACurrent
79672-018OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent
79672-019OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43148ORIG2013-04-10