Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040255
Company: ANI PHARMS

• REMS

Products on ANDA 040255

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 040255

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40255ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-27	REMS - PROPOSAL - D-N-A		Label is not available on this site.
06/29/2017	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/13/2004	SUPPL-6	Labeling		Label is not available on this site.
03/21/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
08/21/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.