Application 204029

Type: ANDA
Sponsor: ABON PHARMS LLC

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
A204029-001	CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS			2017-05-09

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	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204029-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204029-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204029-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204029-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204029-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204029-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204029-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204029-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204029-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204029-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204029-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204029-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204029-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204029-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204029-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204029-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204029-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204029-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204029-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204029-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204029-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204029-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204029-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204029-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204029-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204029-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204029-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204029-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204029-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204029-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204029-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204029-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204029-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204029-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOFARABINE	CLOFARABINE	Zydus Lifesciences Limited	4d8d8e81-01ba-4493-b458-7f6375c5bbae	2022-10-18		Exact identifier application applno (ANDA): 204029 application number: ANDA204029 ndc (product): 49315-003
CLOFARABINE	CLOFARABINE	Fresenius Kabi USA, LLC	fe6ff0f9-7610-4a69-9b75-da7ec4bb7744	2020-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204029 application number: ANDA204029 ndc (product): 63323-572

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49315-003	CLOFARABINE	clofarabine	Cadila Healthcare Limited	ANDA	Current
49315-003	CLOFARABINE	clofarabine	Zydus Lifesciences Limited	ANDA	Current
63323-572	CLOFARABINE	clofarabine	Fresenius-Kabi	ANDA	Current
63323-572	CLOFARABINE	clofarabine	Fresenius Kabi USA, LLC	ANDA	Current
63323-572	CLOFARABINE	clofarabine	Fresenius-Kabi	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48375	ORIG	2017-05-15
48366	ORIG	2017-05-12