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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202521-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202521-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202521-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202521-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Inc5bfb3984-2b47-4e06-9bbb-d055ebc376c82024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202521
application number: ANDA202521
ndc (product): 0781-3415
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Incaff1505c-8d34-46e6-9559-c5b1128878752024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202521
application number: ANDA202521
ndc (product): 0781-3312

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

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