Application 207474

Type: ANDA
Sponsor: ACCORD HLTHCARE

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 44.

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	Approval date
A207474-001	OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21
A207474-002	OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21
A207474-003	OXALIPLATIN	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207474-001	AP
A207474-002	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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207474-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2017-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207474-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207474-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2017-03-21	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207474-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207474-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207474-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207474-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207474-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207474-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207474-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207474-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207474-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207474-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207474-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207474-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207474-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207474-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207474-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207474-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207474-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207474-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207474-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207474-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207474-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207474-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207474-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207474-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207474-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207474-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207474-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207474-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207474-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207474-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207474-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207474-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207474-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207474-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207474-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207474-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207474-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207474-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207474-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207474-002	AP	1	`4b0b4de00fa7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxaliplatin	OXALIPLATIN	Accord Healthcare Inc.	4b805925-beb1-2bac-e054-00144ff88e88	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207474 application number: ANDA207474 ndc (product): 16729-332

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-332	OXALIPLATIN	OXALIPLATIN	Accord Healthcare Inc.	ANDA	Current
16729-332	OXALIPLATIN	OXALIPLATIN	Accord Healthcare Inc.	ANDA	Current
16729-332	OXALIPLATIN	OXALIPLATIN	Accord Healthcare Inc.	ANDA	Current
16729-332	oxaliplatin	oxaliplatin	Accord Healthcare Inc.	ANDA	Current
16729-332	oxaliplatin	oxaliplatin	Accord Healthcare Inc.	ANDA	Current