Application 207323

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CISPLATIN	CISPLATIN	INJECTABLE;INJECTION	1MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207323-001	CISPLATIN	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP		2017-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207323-001	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 2 · 42 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	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207323-001	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	2017-03-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A207323-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207323-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207323-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207323-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207323-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207323-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207323-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207323-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207323-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207323-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207323-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207323-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207323-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207323-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207323-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207323-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207323-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207323-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207323-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207323-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207323-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207323-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207323-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207323-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207323-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207323-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207323-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207323-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207323-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207323-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207323-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207323-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207323-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207323-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207323-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207323-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207323-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207323-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207323-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207323-001	AP	1	`e64feba35796…`

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
CISPLATIN	CISPLATIN	FOSUN PHARMA USA INC	0219eae9-82b4-b779-e063-6394a90a311e	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207323 application number: ANDA207323
Cisplatin	CISPLATIN	Sagent Pharmaceuticals	00396546-6a80-4b9f-a5f8-c22c1d1bb173	2024-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207323 application number: ANDA207323
CISPLATIN	CISPLATIN	BluePoint Laboratories	0372598e-4837-43c6-b56f-63527ac94559	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207323 application number: ANDA207323
CISPLATIN	CISPLATIN	Gland Pharma Limited	a32820f7-9ff6-4c13-a96a-4483a943fe82	2023-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207323 application number: ANDA207323 ndc (product): 68083-163 ndc (product): 68083-162

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-609	Cisplatin	cisplatin	Alvogen Inc.	ANDA	Current
47781-609	Cisplatin	cisplatin	Alvogen Inc.	ANDA	Current
47781-610	Cisplatin	cisplatin	Alvogen Inc.	ANDA	Current
47781-610	Cisplatin	cisplatin	Alvogen Inc.	ANDA	Current
68083-162	CISPLATIN	Cisplatin	Gland Pharma Limited	ANDA	Current
68083-163	CISPLATIN	Cisplatin	Gland Pharma Limited	ANDA	Current
70860-206	Cisplatin	cisplatin	Athenex Pharmaceutical Division, LLC.	ANDA	Current