Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075837
Company: FRESENIUS KABI USA

Products on ANDA 075837

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOXURIDINE	FLOXURIDINE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075837

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75837ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075837.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2002	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
11/26/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/26/2002	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/26/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075837

FLOXURIDINE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLOXURIDINE	FLOXURIDINE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075837	FRESENIUS KABI USA
FLOXURIDINE	FLOXURIDINE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075387	HIKMA