Application 090724

Type: ANDA
Sponsor: AREVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	INJECTABLE;INJECTION	50MG/2ML (25MG/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
A090724-001	FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	50MG/2ML (25MG/ML)	INJECTABLE / INJECTION	AP1		2010-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090724-001	AP1

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.

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
2026-08-01 22:54:32	2026-06	A090724-001	FLUDARABINE PHOSPHATE	50MG/2ML (25MG/ML)	INJECTABLE / INJECTION	AP1		2010-09-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090724-001	AP1	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Areva Pharmaceuticals	8039c2e3-ffe5-3997-e053-2991aa0ad9d0	2023-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090724 application number: ANDA090724 ndc (product): 59923-604
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Lannett Company, Inc.	0170c0f4-d502-4f8f-bdbf-6439f3ed33fb	2023-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090724 application number: ANDA090724

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
59923-604	Fludarabine Phosphate	Fludarabine Phosphate	Areva Pharmaceuticals	ANDA	Current
59923-604	Fludarabine Phosphate	Fludarabine Phosphate	Areva Pharmaceuticals	ANDA	Current
59923-604	Fludarabine Phosphate	Fludarabine Phosphate	Areva Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79641	SUPPL	2024-09-17