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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204378
Company: AM REGENT

Products on ANDA 204378

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204378

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/12/2017	ORIG-1	Approval				Label is not available on this site.

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