Application 076806

Type: ANDA
Sponsor: DR REDDYS

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 43.

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
A076806-001	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION			2006-03-31
A076806-002	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION			2006-03-31

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076806-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	2006-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076806-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	2006-03-31	`74a2ff9319b5…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Deferoxamine	DEFEROXAMINE MESYLATE	Fresenius Kabi USA, LLC	d91e16df-8daa-4cd2-86a2-273eaa2446e0	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: DEFEROXAMINE MESYLATE
Deferoxamine mesylate	DEFEROXAMINE MESYLATE	Apotex Corp.	c99553fb-3fae-b88a-6c2c-efa7520197f9	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Deferoxamine mesylate generic name: DEFEROXAMINE MESYLATE
Deferoxamine Mesylate	DEFEROXAMINE MESYLATE	Hospira, Inc.	f9ab6b1c-98d0-4373-0e9b-b10cb4a67543	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Deferoxamine Mesylate generic name: DEFEROXAMINE MESYLATE
Deferoxamine mesylate	DEFEROXAMINE MESYLATE	Gland Pharma Limited	598fba68-f46e-4b6e-894c-63c2940b2063	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Deferoxamine mesylate generic name: DEFEROXAMINE MESYLATE
Desferal	DEFEROXAMINE MESYLATE	MITEM PHARMA	38eff751-96c5-c48a-e063-6294a90a0e48	2025-07-02		Name fallback generic name: DEFEROXAMINE MESYLATE
Desferal	DEFEROXAMINE MESYLATE	Novartis Pharmaceuticals Corporation	a7174843-5965-49fc-b842-f7eff7b48bbc	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: DEFEROXAMINE MESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.