Application 016267

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESFERAL	DEFEROXAMINE MESYLATE	INJECTABLE;INJECTION	500MG/VIAL	Yes	Yes
002	DESFERAL	DEFEROXAMINE MESYLATE	INJECTABLE;INJECTION	2GM/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N016267-001	DESFERAL	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016267-002	DESFERAL	DEFEROXAMINE MESYLATE	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016267-001	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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2000-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2000-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2000-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2000-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N016267-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016267-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016267-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016267-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016267-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016267-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016267-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016267-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016267-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016267-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016267-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016267-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016267-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016267-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016267-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016267-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016267-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016267-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016267-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016267-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016267-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016267-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016267-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016267-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016267-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016267-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016267-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016267-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016267-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016267-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016267-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016267-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016267-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016267-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016267-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016267-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016267-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016267-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016267-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016267-001	AP	1	`a67488948f0b…`

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
Desferal	DEFEROXAMINE MESYLATE	MITEM PHARMA	38eff751-96c5-c48a-e063-6294a90a0e48	2025-07-02		Exact identifier application applno (NDA): 016267 application number: NDA016267
Desferal	DEFEROXAMINE MESYLATE	Novartis Pharmaceuticals Corporation	a7174843-5965-49fc-b842-f7eff7b48bbc	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016267 application number: NDA016267 ndc (product): 0078-0467

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0467	Desferal	deferoxamine mesylate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0467	Desferal	deferoxamine mesylate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0467	Desferal	deferoxamine mesylate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0467	Desferal	deferoxamine mesylate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0467	Desferal	deferoxamine mesylate	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0467	Desferal	deferoxamine mesylate	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72068	SUPPL	2022-09-13
72066	SUPPL	2022-09-12
12980	SUPPL	2011-12-21
10876	SUPPL	2011-12-20
33150	SUPPL	2010-09-10
12979	SUPPL	2010-09-09
10875	SUPPL	2009-02-04
426	SUPPL	2009-01-30
425	SUPPL	2007-01-25
33149	SUPPL	2007-01-24
424	SUPPL	2002-02-14
423	SUPPL	2001-04-09