Oxycodone And Acetaminophen

ANDA 207574, held by Pharmazone. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 207574 (Oxycodone And Acetaminophen), held by Pharmazone, was first approved by FDA on Dec 13, 2016, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 13, 2016
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 13, 2016	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone And Acetaminophen325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 14REMS	Approved	None posted
Jan 6, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Nov 20, 2024	Supplement 11REMS	Approved	None posted
Sep 19, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 6REMS	Approved	None posted
Dec 13, 2016	Original application	Approved	REMS

Identifiers

Application: ANDA 207574
Drugs@FDA: Overview at FDA
Company: Pharmazone

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