FDA.reportPublic FDA data

Application 201533

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201533-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21
A201533-002PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201533-002AP

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 22:54:322026-06A201533-001PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2016-04-21a50c72e98297…
2026-08-01 22:54:322026-06A201533-002PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAPRS2016-04-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201533-002AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRONNorthStar Rx LLC689c953c-2120-2546-67a4-22bb34ba33302025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201533
application number: ANDA201533
ndc (product): 16714-834
PalonosetronPALONOSETRONBluePoint Laboratoriesee6f6f94-1ca7-481e-9909-b19ae64e80c22025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201533
application number: ANDA201533
ndc (product): 68001-355
PalonosetronPALONOSETRONDr.Reddy's Laboratories Limited991b8452-852c-c55c-7b1b-e97c4964777a2020-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201533
application number: ANDA201533
ndc (product): 55111-694

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
16714-834PalonosetronPalonosetronNorthStar Rx LLCANDACurrent
16714-834PalonosetronPalonosetronNorthStar Rx LLCANDACurrent
16714-834PalonosetronPalonosetronNorthStar Rx LLCANDACurrent
16714-834PalonosetronPalonosetronNorthStar Rx LLCANDACurrent
16714-834PalonosetronPalonosetronNorthStar Rx LLCANDACurrent
55111-694PalonosetronPalonosetronDr.Reddy's Laboratories LimitedANDACurrent
55111-694PalonosetronPalonosetronDr.Reddy's Laboratories LimitedANDACurrent
55111-694PalonosetronPalonosetronDr.Reddy's Laboratories LimitedANDACurrent
68001-355PalonosetronPalonosetronBluePoint LaboratoriesANDACurrent
68001-355PalonosetronPalonosetronBluePoint LaboratoriesANDACurrent
68001-355PalonosetronPalonosetronBluePoint LaboratoriesANDACurrent
68001-355PalonosetronPalonosetronBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9909ORIG2016-04-22
32117ORIG2011-11-21