Application 077790

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	INJECTABLE;INJECTION	50MG/VIAL	No	Yes

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
A077790-001	FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077790-001	FLUDARABINE PHOSPHATE	50MG/VIAL	INJECTABLE / INJECTION			2007-04-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077790-001	AP	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A077790-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077790-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077790-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077790-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077790-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077790-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077790-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077790-001	AP	1	`ea99ee380514…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludarabine	FLUDARABINE PHOSPHATE	Fresenius Kabi USA, LLC	cf5255cc-91fd-4132-973b-764dba142eae	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUDARABINE PHOSPHATE
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Areva Pharmaceuticals	8039c2e3-ffe5-3997-e053-2991aa0ad9d0	2023-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine Phosphate generic name: FLUDARABINE PHOSPHATE
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Lannett Company, Inc.	0170c0f4-d502-4f8f-bdbf-6439f3ed33fb	2023-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine Phosphate generic name: FLUDARABINE PHOSPHATE
Fludarabine phosphate	FLUDARABINE PHOSPHATE	Actavis Pharma, Inc.	3adca34b-4f65-4e21-8058-3c01fc7fc9bb	2022-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine phosphate generic name: FLUDARABINE PHOSPHATE
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Sagent Pharmaceuticals	20e5acf0-90b7-45c8-be78-91eaf77c9ac0	2021-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine Phosphate generic name: FLUDARABINE PHOSPHATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61703-344	Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Hospira, Inc.	ANDA	Current
61703-344	Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Hospira, Inc.	ANDA	Current
61703-344	Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Hospira, Inc.	ANDA	Current