Application 212501

Type: NDA
Sponsor: INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	500MG/2.5ML	No	No
002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	1G/5ML	No	No
003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	SOLUTION;INTRAVENOUS	2G/10ML (200MG/ML)	Yes	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	RLD / RS	Approval date
N212501-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30
N212501-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30
N212501-003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N212501-001	AP
N212501-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N212501-001	10993952	2036-02-15	Drug product	2021-05-04
N212501-001	12329767	2036-02-15	Drug product	2025-07-17
N212501-002	10993952	2036-02-15	Drug product	2021-05-04
N212501-002	12329767	2036-02-15	Drug product	2025-07-17
N212501-003	10993952	2036-02-15	Drug product	2022-03-28
N212501-003	12329767	2036-02-15	Drug product	2025-07-17

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 3 · 110 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	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N212501-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212501-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212501-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-002	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212501-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212501-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`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
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	BluePoint Laboratories	0afd2cc7-09e6-481a-afea-9d2e3742da46	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212501 application number: NDA212501 ndc (product): 68001-564 ndc (product): 68001-565 ndc (product): 68001-563
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Dr. Reddy's Labratories Inc.	a5818647-d840-e9d7-c7b8-6541b485e44e	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212501 application number: NDA212501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-519	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-519	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-519	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-519	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-519	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-519	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-520	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-520	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-520	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-520	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-520	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-520	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-521	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-521	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
50742-521	CYCLOPHOSPHAMIDE	cyclophosphamide	Ingenus Pharmaceuticals, LLC	NDA	Current
68001-563	CYCLOPHOSPHAMIDE	cyclophosphamide	BluePoint Laboratories	NDA	Current
68001-564	CYCLOPHOSPHAMIDE	cyclophosphamide	BluePoint Laboratories	NDA	Current
68001-565	CYCLOPHOSPHAMIDE	cyclophosphamide	BluePoint Laboratories	NDA	Current
70860-218	Cyclophosphamide	cyclophosphamide	Athenex Pharmaceutical Division, LLC.	NDA	Current
70860-218	Cyclophosphamide	cyclophosphamide	Athenex Pharmaceutical Division, LLC.	NDA	Current
70860-218	Cyclophosphamide	cyclophosphamide	Athenex Pharmaceutical Division, LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81573	SUPPL	2025-03-14
81549	SUPPL	2025-03-13
78939	SUPPL	2024-07-01
78902	SUPPL	2024-06-26
68589	SUPPL	2021-09-13
68573	SUPPL	2021-09-10
68081	ORIG	2021-07-14
64180	ORIG	2020-08-03
64161	ORIG	2020-07-31