Drugs@FDA: FDA Approved Drug Products

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

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

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