Application 205648

Type: ANDA
Sponsor: QILU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	No	No
002	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205648-001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2018-09-19
A205648-002	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2018-09-19

Therapeutic equivalence codes#

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

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

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	2018-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		2018-09-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205648-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205648-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205648-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205648-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205648-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205648-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205648-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205648-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205648-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205648-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205648-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205648-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205648-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205648-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205648-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205648-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205648-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205648-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205648-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205648-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205648-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205648-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205648-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205648-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205648-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205648-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205648-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205648-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205648-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205648-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205648-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205648-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205648-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205648-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205648-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205648-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205648-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205648-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205648-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205648-001	AP	1	`a72a2bbeb626…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Palonosetron	PALONOSETRON HYDROCHLORIDE	BLuePoint Laboratories	bb2be46a-56f7-48b6-bb05-3c6b12c8b1ea	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648
Palonosetron	PALONOSETRON HYDROCHLORIDE	Apotex Corp.	4af600d1-0ab1-41c5-af2f-9dc24cf3c90e	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648
Palonosetron	PALONOSETRON HYDROCHLORIDE	Apotex Corp.	903d7aba-277e-6d28-4fee-fd2d605ab6a9	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648 ndc (product): 60505-6193
Palonosetron	PALONOSETRON HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	633abdc2-a942-4eb2-a0f8-f9f4e727211e	2021-10-18	Warnings, Adverse reactions	Exact 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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-6193	Palonosetron	Palonosetron Hydrochloride	Apotex Corp.	ANDA	Current
60505-6193	Palonosetron	Palonosetron Hydrochloride	Apotex Corp.	ANDA	Current
60505-6193	Palonosetron	Palonosetron Hydrochloride	Apotex Corp.	ANDA	Current
60505-6193	Palonosetron	Palonosetron Hydrochloride	Apotex Corp.	ANDA	Current
67184-0514	Palonosetron	Palonosetron Hydrochloride	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0514	Palonosetron	Palonosetron Hydrochloride	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0514	Palonosetron	Palonosetron Hydrochloride	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0515	Palonosetron	Palonosetron Hydrochloride	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0515	Palonosetron	Palonosetron Hydrochloride	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0515	Palonosetron	Palonosetron Hydrochloride	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
68001-482	Palonosetron	Palonosetron Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-482	Palonosetron	Palonosetron Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-482	Palonosetron	Palonosetron Hydrochloride	BluePoint Laboratories	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54154	ORIG	2018-05-11