Application 209872

Type: ANDA
Sponsor: STI PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	CAPSULE;ORAL	25MG	No	No
002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	CAPSULE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209872-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB		2018-05-07
A209872-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB		2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209872-001	AB
A209872-002	AB

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 · 86 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	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209872-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2018-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209872-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2018-05-07	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A209872-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209872-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209872-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209872-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209872-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209872-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209872-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209872-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209872-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209872-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209872-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209872-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209872-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209872-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209872-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209872-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209872-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209872-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209872-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209872-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209872-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209872-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209872-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209872-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209872-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209872-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209872-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209872-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209872-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209872-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209872-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209872-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209872-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209872-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209872-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209872-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209872-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209872-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209872-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209872-002	AB	1	`74a2ff9319b5…`

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	XGen Pharmaceuticals DJB, Inc.	02e64046-687d-449e-e063-6294a90a6c32	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Alembic Pharmaceuticals Limited	9e699cf7-860e-4c03-9760-0c24d56df2de	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Alembic Pharmaceuticals Inc.	3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea1	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	NorthStar Rx LLC	76f057be-e3da-0a89-e053-2a91aa0a8438	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Hikma Pharmaceuticals USA Inc.	8135b917-882f-4b4c-99b7-fa8ea54af4bf	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Fresenius Kabi USA, LLC	31986d36-a1bf-4903-93a4-ce7386241ba1	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE	Avyxa Pharma, LLC	6f593585-e0dd-48bc-bd2b-c6c787e0b98c	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
Cyclophosphamide	CYCLOPHOSPHAMIDE INJECTION, SOLUTION	Baxter Healthcare Company	34dbffee-80e0-49c3-90e8-95713a0b7fbe	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Baxter Healthcare Corporation	769ded74-6186-40a8-8e44-ceff67287451	2020-08-07	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Baxter Healthcare Company	cef038cc-efab-46d9-99c2-95bb11d6c9bc	2017-03-15	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE generic name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Baxter Healthcare Company	6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe	2017-03-15	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54879-021	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-021	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-021	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-021	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-021	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-022	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-022	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-022	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-022	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current
54879-022	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	STI Pharma LLC	ANDA	Current