Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040260
Company: SUN PHARM INDUSTRIES

• REMS

Products on ANDA 040260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ASPIRIN	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	325MG;4.5MG;0.38MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40260ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2025	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/21/2024	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-20	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/04/2021	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/09/2019	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2018	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-15	REMS - PROPOSAL - D-N-A		Label is not available on this site.
03/07/2017	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/24/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
09/24/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
11/02/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.