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Abbreviated New Drug Application (ANDA): 040203
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;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
03/15/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40203ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40203_Oxycodone%20and%20Acetaminophen.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/11/2019 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-9 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/28/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/28/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

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