Application 209775

Type: ANDA
Sponsor: MSN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOFARABINE	CLOFARABINE	SOLUTION;INTRAVENOUS	20MG/20ML (1MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209775-001	CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209775-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209775-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-12-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209775-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209775-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209775-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209775-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209775-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209775-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209775-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209775-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209775-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209775-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209775-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209775-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209775-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209775-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209775-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209775-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209775-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209775-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209775-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209775-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209775-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209775-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209775-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209775-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209775-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209775-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209775-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209775-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209775-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209775-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209775-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209775-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209775-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209775-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209775-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209775-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209775-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209775-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209775-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209775-001	AP	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clofarabine	CLOFARABINE	Dr.Reddy's Laboratories Inc	0da6764d-5fac-7e0f-ea3e-a5aee55a8b2d	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Clofarabine generic name: CLOFARABINE
CLOFARABINE	CLOFARABINE	Fosun Pharma USA Inc.	e956b1e0-2829-4872-8c09-99462d60e922	2023-02-15	Warnings, Adverse reactions	Name fallback brand name: CLOFARABINE generic name: CLOFARABINE
Clofarabine	CLOFARABINE	Meitheal Pharmaceuticals Inc.	54436453-882e-406b-87a3-049d150101c6	2022-12-12	Warnings, Adverse reactions	Name fallback brand name: Clofarabine generic name: CLOFARABINE
Clofarabine	CLOFARABINE	Gland Pharma Limited	b7d3a96e-0280-4f14-b921-795996f75950	2022-11-21	Warnings, Adverse reactions	Name fallback brand name: Clofarabine generic name: CLOFARABINE
CLOFARABINE	CLOFARABINE	Zydus Lifesciences Limited	4d8d8e81-01ba-4493-b458-7f6375c5bbae	2022-10-18		Name fallback brand name: CLOFARABINE generic name: CLOFARABINE
CLOFARABINE	CLOFARABINE	Eugia US LLC	18adf4af-63ed-41e6-ab59-87085ce3e5fb	2022-10-10	Warnings, Adverse reactions	Name fallback brand name: CLOFARABINE generic name: CLOFARABINE
Clofarabine	CLOFARABINE	Amneal Pharmaceuticals LLC	0a273a2d-a1ff-412a-925e-696648730dae	2022-08-23	Warnings, Adverse reactions	Name fallback brand name: Clofarabine generic name: CLOFARABINE
CLOFARABINE	CLOFARABINE	Fresenius Kabi USA, LLC	fe6ff0f9-7610-4a69-9b75-da7ec4bb7744	2020-07-14	Warnings, Adverse reactions	Name fallback brand name: CLOFARABINE generic name: CLOFARABINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-6166	Clofarabine	clofarabine	Apotex Corp.	ANDA	Current
60505-6166	Clofarabine	clofarabine	Apotex Corp.	ANDA	Current
60505-6166	Clofarabine	clofarabine	Apotex Corp.	ANDA	Current
60505-6166	Clofarabine	clofarabine	Apotex Corp.	ANDA	Current