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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091299
Company: SANDOZ

Products on ANDA 091299

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091299

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2011	ORIG-1	Approval				Label is not available on this site.

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