Application 208171

Type: NDA
Sponsor: PHARMACOSMOS AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONOFERRIC	FERRIC DERISOMALTOSE	SOLUTION;INTRAVENOUS	100MG/ML (100MG/ML)	Yes	Yes
002	MONOFERRIC	FERRIC DERISOMALTOSE	SOLUTION;INTRAVENOUS	500MG/5ML (100MG/ML)	Yes	Yes
003	MONOFERRIC	FERRIC DERISOMALTOSE	SOLUTION;INTRAVENOUS	1GM/10ML (100MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208171-001	MONOFERRIC	FERRIC DERISOMALTOSE	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16
N208171-002	MONOFERRIC	FERRIC DERISOMALTOSE	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16
N208171-003	MONOFERRIC	FERRIC DERISOMALTOSE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208171-001	10414831	2029-03-25		Drug substance, Drug product	2020-02-14
N208171-001	11851504	2029-03-25		Drug substance, Drug product	2024-01-11
N208171-001	12030962	2029-03-25		Drug substance, Drug product	2024-08-05
N208171-001	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14
N208171-001	11633489	2036-06-22	U-3594		2023-05-24
N208171-002	10414831	2029-03-25		Drug substance, Drug product	2020-02-14
N208171-002	11851504	2029-03-25		Drug substance, Drug product	2024-01-11
N208171-002	12030962	2029-03-25		Drug substance, Drug product	2024-08-05
N208171-002	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14
N208171-002	11633489	2036-06-22	U-3594		2023-05-24
N208171-003	10414831	2029-03-25		Drug substance, Drug product	2020-02-14
N208171-003	11851504	2029-03-25		Drug substance, Drug product	2024-01-11
N208171-003	12030962	2029-03-25		Drug substance, Drug product	2024-08-05
N208171-003	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14
N208171-003	11633489	2036-06-22	U-3594		2023-05-24

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 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208171-002	MONOFERRIC	500MG/5ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208171-003	MONOFERRIC	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208171-001	MONOFERRIC	100MG/ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-01-16	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 386 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208171-001	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-001	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-001	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-001	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-001	11633489	2036-06-22	U-3594		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-002	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-002	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-002	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-002	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-002	11633489	2036-06-22	U-3594		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-003	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-003	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-003	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-003	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208171-003	11633489	2036-06-22	U-3594		2023-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208171-001	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-001	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-001	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-001	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-001	11633489	2036-06-22	U-3594		2023-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-002	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-002	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-002	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-002	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-002	11633489	2036-06-22	U-3594		2023-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-003	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-003	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-003	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-003	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208171-003	11633489	2036-06-22	U-3594		2023-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208171-001	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-001	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-001	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-001	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-001	11633489	2036-06-22	U-3594		2023-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-002	10414831	2029-03-25		Drug substance, Drug product	2020-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-002	11851504	2029-03-25		Drug substance, Drug product	2024-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-002	12030962	2029-03-25		Drug substance, Drug product	2024-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-002	8815301	2029-08-14	U-2734	Drug substance, Drug product	2020-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208171-002	11633489	2036-06-22	U-3594		2023-05-24	`011fe1cb6892…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Monoferric	FERRIC DERISOMALTOSE	Pharmacosmos Therapeutics Inc.	55859d2d-0456-4fa9-b41f-f535accc97db	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208171 application number: NDA208171 ndc (product): 73594-9301 ndc (product): 73594-9310 ndc (product): 73594-9305

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49442-9301	Monoferric	Ferric derisomaltose	Pharmacosmos A/S	NDA	Current
49442-9305	Monoferric	Ferric derisomaltose	Pharmacosmos A/S	NDA	Current
49442-9310	Monoferric	Ferric derisomaltose	Pharmacosmos A/S	NDA	Current
73594-9301	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9301	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9301	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9301	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9301	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9301	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9305	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9305	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9305	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9305	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9305	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9305	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9310	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9310	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9310	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9310	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9310	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current
73594-9310	Monoferric	Ferric derisomaltose	Pharmacosmos Therapeutics Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79299	SUPPL	2024-08-02
79288	SUPPL	2024-08-02
71732	SUPPL	2022-08-05
71725	SUPPL	2022-08-05
64618	SUPPL	2020-09-21
64573	SUPPL	2020-09-14
62846	ORIG	2020-05-07
61600	ORIG	2020-01-17
61586	ORIG	2020-01-16