Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078316
Company: BARR LABS INC

• REMS

Products on ANDA 078316

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 078316

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2007	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
03/11/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/11/2024	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		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.
10/07/2019	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-8	REMS - PROPOSAL - D-N-A		Label is not available on this site.
02/28/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.