Application 216958

Type: ANDA
Sponsor: HIKMA

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 43.

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
A216958-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18
A216958-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18
A216958-003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216958-001	AP
A216958-002	AP
A216958-003	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 2 · 57 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
2026-09-14 22:38:34	2026-08	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216958-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216958-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216958-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2023-12-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216958-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216958-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216958-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216958-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216958-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216958-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216958-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216958-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216958-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216958-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216958-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216958-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216958-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216958-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216958-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216958-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216958-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216958-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216958-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216958-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216958-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216958-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216958-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216958-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216958-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216958-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216958-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216958-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216958-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216958-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216958-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216958-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216958-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216958-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216958-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216958-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216958-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216958-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216958-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216958-001	AP	1	`301d65b070ca…`

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclophosphamide	CYCLOPHOSPHAMIDE	Nexus Pharmaceuticals, LLC	c961a1ac-6705-4756-9abc-9d84a6fcb5c8	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Frindovyx	CYCLOPHOSPHAMIDE	AVYXA Pharma, LLC	5ad8ea65-4c98-487a-9c8d-df778765ec5e	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	BluePoint Laboratories	1d3396d8-4c03-4a28-890a-d87c6c53a74e	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	BluePoint Laboratories	d7e97b99-83db-42d0-8521-b87fe6467a67	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Avenacy, LLC	1de02105-9c5b-4d11-bddf-bf8450d88b78	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Amneal Pharmaceuticals LLC	520bfe39-dfd5-4a20-9a37-80078afded0d	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Bamboo US Bidco LCC	2873b99a-830d-0a7b-e063-6394a90a4de7	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Epic Pharma, LLC	988d2f71-1dc7-45b5-b2df-187e68224973	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Civica, Inc.	8627c83f-c057-495d-9f78-8b67bda97b3e	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	BluePoint Laboratories	0afd2cc7-09e6-481a-afea-9d2e3742da46	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Baxter Healthcare Company	591d9955-3d9c-4cdc-a308-2f1288376b9f	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Baxter Healthcare Company	97ab446f-5017-4180-ae65-0a355289b0ed	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Eugia US LLC	3c1eb470-0bba-457d-94e3-b9508f0d398a	2025-04-21	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE FOR INJECTION	Slate Run Pharmaceuticals, LLC	20bda486-cb9a-4d67-8c41-50e9fd066434	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Dr. Reddy's Labratories Inc.	a5818647-d840-e9d7-c7b8-6541b485e44e	2025-03-11	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Sandoz Inc.	0e9e22fa-178a-42fc-9f82-c303db3b245a	2025-03-05	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Sagent Pharmaceuticals	329b5a3a-c7b9-4b11-abf0-009719cdfb79	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Cipla USA Inc.	0e1cb955-99c8-4fe5-89d1-399c8e52174e	2025-01-10	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE FOR INJECTION	Hainan Poly Pharm. Co., Ltd.	6fde2705-a2d8-4d48-9618-b9d99d051373	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Sandoz Inc	cf2f4b95-0327-499a-a5a3-51b1bdef68c5	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.