Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040535
Company: WATSON LABS

• REMS

Products on ANDA 040535

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040535

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2003	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
12/23/2025	SUPPL-41	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-40	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/29/2024	SUPPL-39	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/29/2024	SUPPL-38	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-37	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-36	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-35	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/08/2019	SUPPL-34	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-33	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/21/2018	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-31	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
07/19/2011	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/19/2008	SUPPL-17	Labeling		Label is not available on this site.
03/20/2008	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.