Application 208615

Type: ANDA
Sponsor: SCINOPHARM TAIWAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	2.5MG/0.5ML	No	No
002	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	5MG/0.4ML	No	No
003	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	7.5MG/0.6ML	No	No
004	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	INJECTABLE;SUBCUTANEOUS	10MG/0.8ML	No	No

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	Approval date
A208615-001	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14
A208615-002	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	5MG/0.4ML (5MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14
A208615-003	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	7.5MG/0.6ML (7.5MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14
A208615-004	FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	10MG/0.8ML (10MG/0.8ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208615-001	AP
A208615-002	AP
A208615-003	AP
A208615-004	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML (5MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML (7.5MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML (10MG/0.8ML)	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	SOLUTION / SUBCUTANEOUS	AP	2018-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-001	FONDAPARINUX SODIUM	2.5MG/0.5ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-002	FONDAPARINUX SODIUM	5MG/0.4ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-003	FONDAPARINUX SODIUM	7.5MG/0.6ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-004	FONDAPARINUX SODIUM	10MG/0.8ML	INJECTABLE / SUBCUTANEOUS	AP	2018-11-14	`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	A208615-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208615-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208615-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208615-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208615-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208615-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208615-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208615-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208615-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208615-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208615-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208615-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208615-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208615-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208615-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208615-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208615-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208615-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208615-004	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
fondaparinux sodium	FONDAPARINUX SODIUM	Zydus Pharmaceuticals (USA) Inc.	dffbf7c9-495e-4a33-ac76-57b52f014fc2	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208615 application number: ANDA208615 ndc (product): 70710-1515 ndc (product): 70710-1514 ndc (product): 70710-1517 ndc (product): 70710-1516
fondaparinux sodium	FONDAPARINUX SODIUM	Italfarmaco S.p.A	58789e3d-e5bc-4c2e-a527-495a252fcecd	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208615 application number: ANDA208615 ndc (product): 11797-156 ndc (product): 11797-154 ndc (product): 11797-157 ndc (product): 11797-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11797-154	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-154	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-154	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-155	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-155	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-155	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-156	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-156	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-156	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-157	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-157	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
11797-157	fondaparinux sodium	fondaparinux sodium	Italfarmaco S.p.A	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1514	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1515	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1516	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1517	fondaparinux sodium	fondaparinux sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current