FDA.reportPublic FDA data

Application 205648

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)NoNo
002PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.075MG BASE/1.5ML (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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205648-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19
A205648-002PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205648-001AP

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 22:54:322026-06A205648-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19a50c72e98297…
2026-08-01 22:54:322026-06A205648-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205648-001AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRON HYDROCHLORIDEBLuePoint Laboratoriesbb2be46a-56f7-48b6-bb05-3c6b12c8b1ea2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.4af600d1-0ab1-41c5-af2f-9dc24cf3c90e2025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.903d7aba-277e-6d28-4fee-fd2d605ab6a92025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
ndc (product): 60505-6193
PalonosetronPALONOSETRON HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.633abdc2-a942-4eb2-a0f8-f9f4e727211e2021-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205648
application number: ANDA205648
ndc (product): 67184-0515
ndc (product): 67184-0514

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
67184-0514PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0514PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0514PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0515PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0515PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0515PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
68001-482PalonosetronPalonosetron HydrochlorideBluePoint LaboratoriesANDACurrent
68001-482PalonosetronPalonosetron HydrochlorideBluePoint LaboratoriesANDACurrent
68001-482PalonosetronPalonosetron HydrochlorideBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54154ORIG2018-05-11