Application 021345

Type: NDA
Sponsor: MYLAN IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIXTRA	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	2.5MG/0.5ML	Yes	Yes
002	ARIXTRA	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	5MG/0.4ML	Yes	Yes
003	ARIXTRA	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	7.5MG/0.6ML	Yes	Yes
004	ARIXTRA	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	10MG/0.8ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021345-001	ARIXTRA	FONDAPARINUX SODIUM	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2001-12-07
N021345-002	ARIXTRA	FONDAPARINUX SODIUM	5MG/0.4ML (5MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28
N021345-003	ARIXTRA	FONDAPARINUX SODIUM	7.5MG/0.6ML (7.5MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28
N021345-004	ARIXTRA	FONDAPARINUX SODIUM	10MG/0.8ML (10MG/0.8ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021345-001	AP
N021345-002	AP
N021345-003	AP
N021345-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	N021345-001	ARIXTRA	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021345-002	ARIXTRA	5MG/0.4ML (5MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021345-003	ARIXTRA	7.5MG/0.6ML (7.5MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021345-004	ARIXTRA	10MG/0.8ML (10MG/0.8ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021345-001	ARIXTRA	2.5MG/0.5ML	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021345-002	ARIXTRA	5MG/0.4ML	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021345-003	ARIXTRA	7.5MG/0.6ML	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021345-004	ARIXTRA	10MG/0.8ML	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-001	ARIXTRA	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2001-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-002	ARIXTRA	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-003	ARIXTRA	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-004	ARIXTRA	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2004-05-28	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021345-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021345-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021345-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021345-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021345-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021345-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021345-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021345-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021345-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021345-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021345-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021345-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021345-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021345-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021345-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021345-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021345-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021345-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021345-004	AP	1	`d8e5a09893c0…`

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
Arixtra	FONDAPARINUX SODIUM	Mylan Institutional LLC	d3b30c68-cf45-4b46-8ba6-72090f7ba01a	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021345 application number: NDA021345 ndc (product): 67457-592 ndc (product): 67457-594 ndc (product): 67457-595 ndc (product): 67457-593
Fondaparinux Sodium	FONDAPARINUX SODIUM	Mylan Institutional LLC	4b65f642-87f7-4da5-a9c9-02cd1f8d9d16	2020-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021345 application number: NDA021345 ndc (product): 67457-584 ndc (product): 67457-582 ndc (product): 67457-583 ndc (product): 67457-585

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-582	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-582	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-582	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-583	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-583	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-583	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-584	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-584	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-584	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-585	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-585	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-585	Fondaparinux Sodium	fondaparinux sodium	Mylan Institutional LLC	NDA AUTHORIZED GENERIC	Current
67457-592	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-592	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-592	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-592	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-592	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-592	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-593	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-593	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-593	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-593	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-593	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-593	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-594	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-594	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-594	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-594	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-594	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-594	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-595	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-595	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-595	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-595	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-595	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current
67457-595	Arixtra	fondaparinux sodium	Mylan Institutional LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80806	SUPPL	2025-01-02
80753	SUPPL	2024-12-27
64554	SUPPL	2020-09-11
64416	SUPPL	2020-08-26
61301	SUPPL	2019-12-17
61280	SUPPL	2019-12-16
49485	SUPPL	2017-08-21
49461	SUPPL	2017-08-18
36710	SUPPL	2014-07-17
5108	SUPPL	2014-07-17
36709	SUPPL	2013-09-17
5107	SUPPL	2013-09-13
15239	SUPPL	2010-04-04
27541	SUPPL	2010-03-31
27542	SUPPL	2009-12-31
15240	SUPPL	2009-12-30
27540	SUPPL	2009-11-25
15238	SUPPL	2009-09-18
27539	SUPPL	2008-10-21
36708	SUPPL	2005-05-27
5106	SUPPL	2005-05-27
27538	SUPPL	2004-06-01
15237	SUPPL	2004-06-01
15236	SUPPL	2004-06-01
5105	SUPPL	2004-06-01
42114	ORIG	2004-05-27
27537	SUPPL	2003-06-22
15235	SUPPL	2003-06-22
27536	SUPPL	2002-12-04
15234	SUPPL	2002-12-04
15233	ORIG	2001-12-07
5104	ORIG	2001-12-07