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 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
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 · 78 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	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…`
2021-12-28 21:50 UTC	2021-12	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	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…`
2021-12-28 21:50 UTC	2021-12	A207321-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207321-001	AP	1	`87673890dc5c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	2025-12-09	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	2025-12-09	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