Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040203
Company: ACTAVIS ELIZABETH

• REMS

Products on ANDA 040203

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040203

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
12/22/2025	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-17	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/12/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/12/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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-Package Insert, Labeling-Medication Guide		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.