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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040910
Company: EPIC PHARMA LLC

REMS

Products on ANDA 040910

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ASPIRIN	ASPIRIN; OXYCODONE HYDROCHLORIDE	325MG;4.8355MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2020	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
03/07/2025	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/21/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-3	REMS-Modified		Label is not available on this site.

Therapeutic Equivalents for ANDA 040910

OXYCODONE AND ASPIRIN

TABLET;ORAL; 325MG;4.8355MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE AND ASPIRIN	ASPIRIN; OXYCODONE HYDROCHLORIDE	325MG;4.8355MG	TABLET;ORAL	Prescription	No	AA	040910	EPIC PHARMA LLC
PERCODAN	ASPIRIN; OXYCODONE HYDROCHLORIDE	325MG;4.8355MG	TABLET;ORAL	Prescription	Yes	AA	007337	ENDO OPERATIONS

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