Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040257
Company: MALLINCKRODT

Products on ANDA 040257

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	500MG;5MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40257_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40257ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040257_oxycodone_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 040257

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40257_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf