Application 207562

Type: ANDA
Sponsor: INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXALIPLATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	50MG/10ML (5MG/ML)	No	No
002	OXALIPLATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	100MG/20ML (5MG/ML)	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207562-001	OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2018-10-16
A207562-002	OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2018-10-16

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207562-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207562-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207562-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207562-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207562-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207562-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207562-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207562-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207562-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207562-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207562-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207562-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207562-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207562-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207562-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207562-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207562-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207562-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207562-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207562-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207562-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207562-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207562-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207562-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207562-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207562-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207562-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207562-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207562-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207562-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207562-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207562-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207562-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207562-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207562-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207562-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207562-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207562-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207562-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207562-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207562-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207562-002	AP	1	`87673890dc5c…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxaliplatin	OXALIPLATIN	Shandong New Time Pharmaceutical Co., Ltd.	1ac38523-480b-4c0f-97a1-7dfa1432923c	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	NorthStar Rx LLC	f299b2d2-86ed-4fb8-822e-65455a0bb75a	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Northstar Rx LLC	7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Camber Pharmaceuticals, Inc.	b0799e39-7b1e-430a-b159-062b39521001	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
oxaliplatin	OXALIPLATIN	Sagent Pharmaceuticals	29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Mylan Institutional LLC	da0e8523-609a-4326-96b1-d7de78662d91	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	BluePoint Laboratories	b6083405-9b45-4d2c-e053-2995a90ad9ef	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Qilu Pharmaceutical Co., Ltd.	33d4f4b4-bb4e-46af-9e89-df20154436d0	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	11377169-7986-45b1-8298-6f0533efa3c3	2024-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Hospira, Inc.	e51a62ba-d163-4c57-835c-8c86cf097e40	2024-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	ee2e0da9-5ae7-405b-8dd1-635be72bc439	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Apotex Corp.	ee5a5a1d-63f6-4d5a-901b-65be45ec6610	2024-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Apotex Corp.	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2024-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Eugia US LLC	1bb4febd-0ed4-48c9-ba2a-e22183a2143f	2024-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	7e38318e-c569-4ad4-8f10-a235f30444d1	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	873fa936-157a-4f85-bc70-5df31d71d122	2024-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
oxaliplatin	OXALIPLATIN	Accord Healthcare Inc.	4b805925-beb1-2bac-e054-00144ff88e88	2024-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: oxaliplatin generic name: OXALIPLATIN
OXALIPLATIN	OXALIPLATIN	Winthrop U.S, a business of sanofi-aventis U.S. LLC	70269278-fe61-4800-a064-32cb6845cc28	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXALIPLATIN generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	FOSUN PHARMA USA INC.	fad0f147-6595-4412-87a7-2afca0192a96	2023-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN
Oxaliplatin	OXALIPLATIN	Gland Pharma Limited	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	2023-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaliplatin generic name: OXALIPLATIN

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-405	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-405	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-405	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-405	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-405	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-405	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-406	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-406	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-406	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-406	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-406	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-406	Oxaliplatin	Oxaliplatin	Ingenus Pharmaceuticals, LLC	ANDA	Current