Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090724
Company: AREVA PHARMS

Products on ANDA 090724

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	50MG/2ML (25MG/ML)	INJECTABLE;INJECTION	Prescription	AP1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090724

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2023	SUPPL-6	Manufacturing (CMC)-Facility	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/090724Orig1s006.pdf

Therapeutic Equivalents for ANDA 090724

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION; 50MG/2ML (25MG/ML)
TE Code = AP1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	50MG/2ML (25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP1	090724	AREVA PHARMS
FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	50MG/2ML (25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP1	078393	FRESENIUS KABI USA
FLUDARABINE PHOSPHATE	FLUDARABINE PHOSPHATE	50MG/2ML (25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP1	076661	SAGENT PHARMS INC