Application 207384

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	INJECTABLE;INJECTION	500MG/VIAL	No	No
002	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	INJECTABLE;INJECTION	2GM/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
A207384-001	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP		2017-09-29
A207384-002	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP		2017-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207384-001	AP
A207384-002	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 · 84 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	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A207384-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207384-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207384-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207384-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207384-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207384-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207384-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207384-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207384-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207384-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207384-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207384-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207384-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207384-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207384-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207384-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207384-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207384-002	AP	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Deferoxamine mesylate	DEFEROXAMINE MESYLATE	Apotex Corp.	c99553fb-3fae-b88a-6c2c-efa7520197f9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207384 application number: ANDA207384 ndc (product): 60505-6237 ndc (product): 60505-6236
Deferoxamine mesylate	DEFEROXAMINE MESYLATE	Gland Pharma Limited	598fba68-f46e-4b6e-894c-63c2940b2063	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207384 application number: ANDA207384 ndc (product): 68083-172 ndc (product): 68083-173

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-623	Deferoxamine mesylate	Deferoxamine mesylate	Alvogen Inc.	ANDA	Current
47781-623	Deferoxamine mesylate	Deferoxamine mesylate	Alvogen Inc.	ANDA	Current
47781-624	Deferoxamine mesylate	Deferoxamine mesylate	Alvogen Inc.	ANDA	Current
47781-624	Deferoxamine mesylate	Deferoxamine mesylate	Alvogen Inc.	ANDA	Current
47781-624	Deferoxamine mesylate	Deferoxamine mesylate	Alvogen Inc.	ANDA	Current
47781-624	Deferoxamine mesylate	Deferoxamine mesylate	Alvogen Inc.	ANDA	Current
52609-4504	Deferoxamine mesylate	Deferoxamine mesylate	ApoPharma USA, Inc.	ANDA	Current
52609-4505	Deferoxamine mesylate	Deferoxamine mesylate	ApoPharma USA, Inc.	ANDA	Current
60505-6236	Deferoxamine mesylate	Deferoxamine mesylate	Apotex Corp.	ANDA	Current
60505-6236	Deferoxamine mesylate	Deferoxamine mesylate	Apotex Corp.	ANDA	Current
60505-6237	Deferoxamine mesylate	Deferoxamine mesylate	Apotex Corp.	ANDA	Current
60505-6237	Deferoxamine mesylate	Deferoxamine mesylate	Apotex Corp.	ANDA	Current
60505-6238	Deferoxamine mesylate	Deferoxamine mesylate	Apotex Corp.	ANDA	Current
68083-172	Deferoxamine mesylate	Deferoxamine mesylate	Gland Pharma Limited	ANDA	Current
68083-173	Deferoxamine mesylate	Deferoxamine mesylate	Gland Pharma Limited	ANDA	Current