Application 021057

Type: NDA
Sponsor: ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GANIRELIX ACETATE	GANIRELIX ACETATE	INJECTABLE;INJECTION	250MCG/0.5ML	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021057-001	GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021057-001	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 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N021057-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021057-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021057-001	AP	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ganirelix Acetate	GANIRELIX ACETATE	Mullan Pharmaceutical Inc.	420ce739-2756-4fb4-8a4e-5fab501ab973	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE
Ganirelix Acetate	GANIRELIX ACETATE	Xiromed LLC	37a8e041-9751-665a-1965-765f7ff21922	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE
Ganirelix Acetate	GANIRELIX ACETATE	Lupin Pharmaceuticals, Inc.	e50888ef-5e66-4b15-bdc3-2f6794f09246	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE
Ganirelix Acetate	GANIRELIX ACETATE	Qilu Pharmaceutical Co., Ltd.	440f6d67-f02e-4407-8830-39c394e25e5d	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE
Ganirelix Acetate	GANIRELIX ACETATE	Meitheal Pharmaceuticals Inc.	1f067dfb-f9c7-4020-ab7b-da2ba695ab32	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE
Fyremadel	GANIRELIX ACETATE	Ferring Pharmaceuticals Inc.	5f0908b5-3551-47fd-95f7-3669b0dff7f1	2025-01-06	Warnings, Adverse reactions	Name fallback generic name: GANIRELIX ACETATE
Ganirelix Acetate	GANIRELIX ACETATE	Fresenius Kabi USA, LLC	c23ca7b2-7350-4f07-8adf-046bffb47842	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE
GANIRELIX ACETATE	GANIRELIX ACETATE	Gland Pharma Limited	cad7c09c-234b-4e73-b460-a1b1f7adc28d	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: GANIRELIX ACETATE generic name: GANIRELIX ACETATE
Ganirelix Acetate	GANIRELIX ACETATE	Amphastar Pharmaceuticals, Inc.	9c286f64-8039-44ec-8fdd-d1a2f52b4c3c	2022-04-19	Warnings, Adverse reactions	Name fallback brand name: Ganirelix Acetate generic name: GANIRELIX ACETATE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0052-0301	Ganirelix Acetate	Ganirelix Acetate	Organon USA Inc.	NDA	Current
0052-0301	Ganirelix Acetate	Ganirelix Acetate	Organon USA Inc.	NDA	Current
0052-0301	Ganirelix Acetate	Ganirelix Acetate	Organon USA Inc.	NDA	Current
78206-138	Ganirelix Acetate	Ganirelix Acetate	Organon LLC	NDA	Current
78206-138	Ganirelix Acetate	Ganirelix Acetate	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79728	SUPPL	2024-09-24
79708	SUPPL	2024-09-24
75085	SUPPL	2023-08-16
75084	SUPPL	2023-08-16
75083	SUPPL	2023-08-16
75082	SUPPL	2023-08-16
75076	SUPPL	2023-08-15
75075	SUPPL	2023-08-15
75074	SUPPL	2023-08-15
75073	SUPPL	2023-08-15
65862	SUPPL	2021-01-07
65085	SUPPL	2020-10-30
14259	SUPPL	2015-01-09
4180	SUPPL	2014-12-23
4179	SUPPL	2008-07-02
14258	SUPPL	2008-06-30
21399	ORIG	2004-05-27
14257	ORIG	1999-07-29
4178	ORIG	1999-07-29