Oxycodone And Acetaminophen

ANDA 201447, held by Actavis Elizabeth. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 201447 (Oxycodone And Acetaminophen), held by Actavis Elizabeth, was first approved by FDA on Apr 12, 2013, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2013
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Apr 12, 2013	Original application	Approved	REMS

Products

4 strengths and forms


Oxycodone And Acetaminophen325MG;2.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx
Oxycodone And Acetaminophen325MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Rx

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 27REMS	Approved	None posted
Dec 22, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 23REMS	Approved	None posted
Mar 12, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Mar 12, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 15Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 14REMS	Approved	None posted
Dec 16, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Apr 12, 2013	Original application	Approved	REMS

Identifiers

Application: ANDA 201447
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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