Application 022201

Type: NDA
Sponsor: FERRING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FIRMAGON	DEGARELIX ACETATE	POWDER;SUBCUTANEOUS	EQ 80MG BASE/VIAL	Yes	No
002	FIRMAGON	DEGARELIX ACETATE	POWDER;SUBCUTANEOUS	EQ 120MG BASE/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
N022201-001	FIRMAGON	DEGARELIX ACETATE	EQ 80MG BASE/VIAL	POWDER / SUBCUTANEOUS		RLD	2008-12-24
N022201-002	FIRMAGON	DEGARELIX ACETATE	EQ 120MG BASE/VIAL	POWDER / SUBCUTANEOUS		RLD, RS	2008-12-24

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022201-001	10729739	2029-02-10	U-1978	2020-08-07
N022201-001	10973870	2029-02-10	U-1978	2021-04-13
N022201-001	9579359	2029-02-10	U-1978	2017-03-30
N022201-001	12514898	2029-02-20	U-1978	2026-01-27
N022201-001	12533387	2029-02-20	U-4417	2026-02-25
N022201-001	10695398	2032-04-27	U-1895	2020-07-07
N022201-001	11766468	2032-04-27	U-1978	2023-10-26
N022201-001	11826397	2032-04-27	U-1978	2023-12-15
N022201-001	9415085	2032-04-27	U-1895	2016-09-15
N022201-002	10729739	2029-02-10	U-1978	2020-08-07
N022201-002	10973870	2029-02-10	U-1978	2021-04-13
N022201-002	9579359	2029-02-10	U-1978	2017-03-30
N022201-002	12514898	2029-02-20	U-1978	2026-01-27
N022201-002	12533387	2029-02-20	U-4417	2026-02-25
N022201-002	10695398	2032-04-27	U-1895	2020-07-07
N022201-002	11766468	2032-04-27	U-1978	2023-10-26
N022201-002	11826397	2032-04-27	U-1978	2023-12-15
N022201-002	9415085	2032-04-27	U-1895	2016-09-15

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N022201-001	FIRMAGON	EQ 80MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD	2008-12-24	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022201-002	FIRMAGON	EQ 120MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2008-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022201-001	FIRMAGON	EQ 80MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD	2008-12-24	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022201-002	FIRMAGON	EQ 120MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2008-12-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022201-001	FIRMAGON	EQ 80MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD	2008-12-24	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022201-002	FIRMAGON	EQ 120MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2008-12-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022201-001	FIRMAGON	EQ 80MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD	2008-12-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022201-002	FIRMAGON	EQ 120MG BASE/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2008-12-24	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022201-001	10729739	2029-02-10	U-1978	2020-08-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	10973870	2029-02-10	U-1978	2021-04-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	9579359	2029-02-10	U-1978	2017-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	12514898	2029-02-20	U-1978	2026-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	12533387	2029-02-20	U-4417	2026-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	10695398	2032-04-27	U-1895	2020-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	11766468	2032-04-27	U-1978	2023-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	11826397	2032-04-27	U-1978	2023-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-001	9415085	2032-04-27	U-1895	2016-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	10729739	2029-02-10	U-1978	2020-08-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	10973870	2029-02-10	U-1978	2021-04-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	9579359	2029-02-10	U-1978	2017-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	12514898	2029-02-20	U-1978	2026-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	12533387	2029-02-20	U-4417	2026-02-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	10695398	2032-04-27	U-1895	2020-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	11766468	2032-04-27	U-1978	2023-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	11826397	2032-04-27	U-1978	2023-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022201-002	9415085	2032-04-27	U-1895	2016-09-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022201-001	10729739	2029-02-10	U-1978	2020-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	10973870	2029-02-10	U-1978	2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	9579359	2029-02-10	U-1978	2017-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	12514898	2029-02-20	U-1978	2026-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	12533387	2029-02-20	U-4417	2026-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	10695398	2032-04-27	U-1895	2020-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	11766468	2032-04-27	U-1978	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	11826397	2032-04-27	U-1978	2023-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-001	9415085	2032-04-27	U-1895	2016-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	10729739	2029-02-10	U-1978	2020-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	10973870	2029-02-10	U-1978	2021-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	9579359	2029-02-10	U-1978	2017-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	12514898	2029-02-20	U-1978	2026-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	12533387	2029-02-20	U-4417	2026-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	10695398	2032-04-27	U-1895	2020-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	11766468	2032-04-27	U-1978	2023-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	11826397	2032-04-27	U-1978	2023-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022201-002	9415085	2032-04-27	U-1895	2016-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022201-001	10729739	2029-02-10	U-1978	2020-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022201-001	10973870	2029-02-10	U-1978	2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022201-001	9579359	2029-02-10	U-1978	2017-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022201-001	12514898	2029-02-20	U-1978	2026-01-27	`caaa826d4ba7…`

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
FIRMAGON	DEGARELIX	Ferring Pharmaceuticals Inc.	ab11dd8a-0fd9-4013-89ab-e114557c7e4b	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022201 application number: NDA022201 ndc (product): 55566-8403 ndc (product): 55566-8303

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55566-8303	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8303	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8303	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8303	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8403	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8403	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8403	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current
55566-8403	FIRMAGON	Degarelix	Ferring Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61961	SUPPL	2020-02-26
61959	SUPPL	2020-02-25
38376	SUPPL	2015-11-04
7040	SUPPL	2015-10-28
17078	SUPPL	2015-03-03
7039	SUPPL	2015-02-27
38375	SUPPL	2013-08-21
29397	SUPPL	2013-08-20
17077	SUPPL	2013-03-08
29396	SUPPL	2013-03-06
42447	ORIG	2009-02-17
24258	ORIG	2009-02-17
7038	ORIG	2008-12-30
17076	ORIG	2008-12-29