Application 207325

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
003	OXALIPLATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	200MG/40ML (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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207325-001	OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10
A207325-002	OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10
A207325-003	OXALIPLATIN	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207325-001	AP
A207325-002	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A207325-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207325-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207325-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207325-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207325-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207325-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207325-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207325-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207325-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207325-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207325-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207325-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207325-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207325-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207325-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207325-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207325-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207325-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207325-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207325-001	AP	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	NorthStar Rx LLC	f299b2d2-86ed-4fb8-822e-65455a0bb75a	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325 ndc (product): 72603-101 ndc (product): 72603-301
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	7e38318e-c569-4ad4-8f10-a235f30444d1	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325 ndc (product): 71288-149
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	873fa936-157a-4f85-bc70-5df31d71d122	2024-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325 ndc (product): 71288-101
Oxaliplatin	OXALIPLATIN	FOSUN PHARMA USA INC.	fad0f147-6595-4412-87a7-2afca0192a96	2023-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325 ndc (product): 72266-161 ndc (product): 72266-162
Oxaliplatin	OXALIPLATIN	Gland Pharma Limited	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	2023-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325 ndc (product): 68083-314 ndc (product): 68083-176 ndc (product): 68083-177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-591	Oxaliplatin	oxaliplatin	Alvogen Inc.	ANDA	Current
47781-592	Oxaliplatin	oxaliplatin	Alvogen Inc.	ANDA	Current
51991-922	Oxaliplatin	Oxaliplatin	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-923	Oxaliplatin	Oxaliplatin	Breckenridge Pharmaceutical, Inc.	ANDA	Current
68083-176	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-176	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-176	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-177	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-177	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-177	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-314	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-314	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
68083-314	Oxaliplatin	Oxaliplatin	Gland Pharma Limited	ANDA	Current
70860-201	Oxaliplatin	oxaliplatin	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71288-101	Oxaliplatin	Oxaliplatin	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-101	Oxaliplatin	Oxaliplatin	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-101	Oxaliplatin	Oxaliplatin	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-149	Oxaliplatin	Oxaliplatin	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-149	Oxaliplatin	Oxaliplatin	Meitheal Pharmaceuticals Inc.	ANDA	Current
72266-125	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-125	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-125	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-126	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-126	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-126	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-161	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-161	Oxaliplatin	Oxaliplatin	FOSUN PHARMA USA INC.	ANDA	Current
72266-162	Oxaliplatin	Oxaliplatin	Fosun Pharma USA Inc.	ANDA	Current
72266-162	Oxaliplatin	Oxaliplatin	FOSUN PHARMA USA INC.	ANDA	Current
72603-101	Oxaliplatin	Oxaliplatin	NorthStar Rx LLC	ANDA	Current
72603-101	Oxaliplatin	Oxaliplatin	NorthStar Rx LLC	ANDA	Current
72603-101	Oxaliplatin	Oxaliplatin	NorthStar Rx LLC	ANDA	Current
72603-301	Oxaliplatin	Oxaliplatin	NorthStar Rx LLC	ANDA	Current
72603-301	Oxaliplatin	Oxaliplatin	NorthStar Rx LLC	ANDA	Current
72603-301	Oxaliplatin	Oxaliplatin	NorthStar Rx LLC	ANDA	Current