FDA.reportPublic FDA data

Application 202521

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3312Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3312Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3312Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3312Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3312Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3312Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3415Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3415Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3415Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3415Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3415Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent
0781-3415Palonosetron HydrochloridePalonosetron HydrochlorideSandoz IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32272ORIG2015-10-14