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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075387
Company: HIKMA

Products on ANDA 075387

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075387

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75387ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075387

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

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