Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078769
Company: ACTAVIS ELIZABETH

• REMS

Products on ANDA 078769

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE HYDROCHLORIDE AND IBUPROFEN	IBUPROFEN; OXYCODONE HYDROCHLORIDE	400MG;5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078769

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2024	SUPPL-35	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/27/2024	SUPPL-34	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-22	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/15/2018	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/02/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.