Application 204555

Type: ANDA
Sponsor: JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	500MG/VIAL	No	No
002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	1GM/VIAL	No	No
003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	2GM/VIAL	No	No

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

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	TE codes	Approval date
A204555-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31
A204555-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31
A204555-003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204555-001	AP
A204555-002	AP
A204555-003	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 4 · 126 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	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204555-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204555-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204555-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2014-10-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A204555-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204555-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204555-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204555-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204555-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204555-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204555-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204555-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204555-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204555-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204555-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204555-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204555-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204555-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204555-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204555-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204555-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204555-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204555-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204555-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204555-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204555-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204555-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204555-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204555-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204555-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204555-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204555-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204555-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204555-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204555-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204555-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204555-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204555-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204555-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204555-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204555-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204555-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204555-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204555-001	AP	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclophosphamide	CYCLOPHOSPHAMIDE	Sandoz Inc.	0e9e22fa-178a-42fc-9f82-c303db3b245a	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204555 application number: ANDA204555 ndc (product): 0781-3244 ndc (product): 0781-3255 ndc (product): 0781-3233
Cyclophosphamide	CYCLOPHOSPHAMIDE	NorthStar Rx LLC	76f057be-e3da-0a89-e053-2a91aa0a8438	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204555 application number: ANDA204555 ndc (product): 16714-859 ndc (product): 16714-857 ndc (product): 16714-858
Cyclophosphamide	CYCLOPHOSPHAMIDE	Fresenius Kabi USA, LLC	31986d36-a1bf-4903-93a4-ce7386241ba1	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204555 application number: ANDA204555

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3233	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3233	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3233	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3233	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3244	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3244	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3244	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3244	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3255	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3255	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3255	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
0781-3255	Cyclophosphamide	cyclophosphamide	Sandoz Inc.	ANDA	Current
16714-857	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-857	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-857	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-857	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-858	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-858	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-858	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-858	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-859	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-859	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-859	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current
16714-859	Cyclophosphamide	cyclophosphamide	NorthStar Rx LLC	ANDA	Current