Oxycodone And Aspirin

ANDA 90084, held by Actavis Labs Fl Inc. Aspirin; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 90084 (Oxycodone And Aspirin), held by Actavis Labs Fl Inc, was first approved by FDA on Mar 22, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2011
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 22, 2011	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone And Aspirin325MG;4.8355MG · tablet;oral	Aspirin; Oxycodone Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 15REMS	Approved	None posted
Feb 28, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Nov 21, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 12REMS	Approved	None posted
May 3, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 5REMS	Approved	None posted
Sep 11, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Mar 22, 2011	Original application	Approved	REMS

Identifiers

Application: ANDA 90084
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters