Application 207005

Type
ANDA
Sponsor
HOSPIRA INC

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
A207005-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19
A207005-002PALONOSETRON 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
A207005-001AP

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207005-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUSAP2018-09-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A207005-002PALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE / INTRAVENOUS2018-09-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207005-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207005-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207005-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207005-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207005-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207005-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207005-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207005-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207005-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207005-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207005-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207005-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207005-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207005-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207005-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207005-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207005-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207005-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207005-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207005-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207005-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207005-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207005-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207005-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207005-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207005-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207005-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207005-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207005-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207005-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A207005-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207005-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207005-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207005-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207005-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207005-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207005-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207005-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207005-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207005-001AP19b2671bbb829…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRON HYDROCHLORIDEBLuePoint Laboratoriesbb2be46a-56f7-48b6-bb05-3c6b12c8b1ea2026-07-06Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEEugia US LLC42e2d437-0712-4e9c-9c2a-00093c406d622025-10-30Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.4af600d1-0ab1-41c5-af2f-9dc24cf3c90e2025-06-09Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.903d7aba-277e-6d28-4fee-fd2d605ab6a92025-01-02Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEAvenacy, Inc.0063b66a-a71b-473c-97b8-7c59f2a5b18e2024-05-15Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Inc5bfb3984-2b47-4e06-9bbb-d055ebc376c82024-02-05Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Incaff1505c-8d34-46e6-9559-c5b1128878752024-02-05Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMeitheal Pharmaceuticals Inc.11bb07b2-6530-45ab-a916-ba9dd3107fc32023-08-17Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDECipla USA Inc.37e7ef89-fd77-44e0-9271-ae91f88226032022-01-13Warnings, Adverse reactionsName fallback
brand name: palonosetron hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
PalonosetronPALONOSETRON HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.633abdc2-a942-4eb2-a0f8-f9f4e727211e2021-10-18Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEBaxter Healthcare Corporation0f3bfe3d-75c8-42eb-84be-570f8e251fdd2020-09-15Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMylan Institutional LLC0a781796-bb74-4c5f-8d26-9ce520b818f72020-06-09Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDESagent Pharmaceuticals6e60d03d-eae6-4924-a507-e77ea077c1ab2020-04-28Warnings, Adverse reactionsName fallback
brand name: palonosetron hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDETeva Parenteral Medicines, Inc.911783eb-91a8-4ef4-bd6f-809211e207d62020-04-01Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent