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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087742
Company: ROXANE

Products on ANDA 087742

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ASPIRIN (HALF-STRENGTH)	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	325MG;2.25MG;0.19MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087742

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/1982	ORIG-1	Approval				Label is not available on this site.

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