Application 078817

Type: ANDA
Sponsor: SANDOZ

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
A078817-001	OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2011-01-24
A078817-002	OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2011-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078817-001	AP
A078817-002	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 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	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078817-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078817-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	2011-01-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078817-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078817-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078817-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078817-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078817-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078817-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078817-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078817-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078817-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078817-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078817-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078817-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078817-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078817-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078817-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078817-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078817-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078817-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078817-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078817-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078817-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078817-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078817-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078817-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078817-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078817-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078817-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078817-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078817-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078817-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078817-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078817-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078817-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078817-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078817-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078817-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078817-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078817-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078817-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078817-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	Sandoz Inc	86f6c19d-30d1-42e3-8d46-5e3f45776e85	2023-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078817 application number: ANDA078817 ndc (product): 0781-9317 ndc (product): 0781-9315
Oxaliplatin	OXALIPLATIN	Baxter Healthcare Corporation	21a2bb1d-d91d-4f99-97dd-cc67fe99a090	2023-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078817 application number: ANDA078817 ndc (product): 43066-014 ndc (product): 43066-018
Oxaliplatin	OXALIPLATIN	Sandoz Inc	ab162009-6f84-4d56-ab56-5e84409ec814	2023-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078817 application number: ANDA078817 ndc (product): 0781-3315 ndc (product): 0781-3317

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-3317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9315	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
0781-9317	Oxaliplatin	Oxaliplatin	Sandoz Inc	ANDA	Current
43066-014	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-014	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-014	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-014	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-014	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-018	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-018	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-018	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-018	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
43066-018	Oxaliplatin	Oxaliplatin	Baxter Healthcare Corporation	ANDA	Current
79672-018	Oxaliplatin	OXALIPLATIN	Nextgen Pharmaceuticals LLC	ANDA	Current
79672-019	Oxaliplatin	OXALIPLATIN	Nextgen Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43148	ORIG	2013-04-10