Application 207321

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
002	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207321-001	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-11-28
A207321-002	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP		2019-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207321-001	AP
A207321-002	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 2 · 80 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	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A207321-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207321-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207321-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207321-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207321-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207321-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207321-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207321-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207321-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207321-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207321-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207321-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207321-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207321-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207321-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207321-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207321-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207321-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Almaject, Inc.	9cbd2987-10bb-eceb-153d-ee7be1ed0c84	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321 ndc (product): 72611-716
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Almaject, Inc.	e9550d22-6069-a6de-9968-6a18c9e0448f	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321 ndc (product): 72611-716
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Gland Pharma Limited	c9c625fc-8852-4ed4-bcf2-63f46a706782	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321 ndc (product): 68083-195
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Fosun Pharma USA Inc.	c1d98fbe-5fd9-4518-b1a5-fac92e32928f	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321 ndc (product): 72266-235 ndc (product): 72266-101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-578	Dexrazoxane	Dexrazoxane for Injection	Alvogen Inc.	ANDA	Current
47781-578	Dexrazoxane	Dexrazoxane for Injection	Alvogen Inc.	ANDA	Current
47781-578	Dexrazoxane	Dexrazoxane for Injection	Alvogen Inc.	ANDA	Current
51991-942	Dexrazoxane	Dexrazoxane Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-942	Dexrazoxane	Dexrazoxane Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
68083-195	Dexrazoxane	Dexrazoxane for Injection	Gland Pharma Limited	ANDA	Current
72266-101	Dexrazoxane	Dexrazoxane for Injection	Fosun Pharma USA Inc.	ANDA	Current
72266-101	Dexrazoxane	Dexrazoxane for Injection	Fosun Pharma USA Inc.	ANDA	Current
72266-101	Dexrazoxane	Dexrazoxane for Injection	Fosun Pharma USA Inc.	ANDA	Current
72266-101	Dexrazoxane	Dexrazoxane for Injection	Fosun Pharma USA Inc.	ANDA	Current
72266-235	Dexrazoxane	Dexrazoxane for Injection	Fosun Pharma USA Inc.	ANDA	Current
72266-235	Dexrazoxane	Dexrazoxane for Injection	Fosun Pharma USA Inc.	ANDA	Current
72611-716	Dexrazoxane	Dexrazoxane for Injection	Almaject, Inc.	ANDA	Current
72611-716	Dexrazoxane	Dexrazoxane for Injection	Almaject, Inc.	ANDA	Current
72611-716	Dexrazoxane	Dexrazoxane for Injection	Almaject, Inc.	ANDA	Current
72611-716	Dexrazoxane	Dexrazoxane for Injection	Almaject, Inc.	ANDA	Current