Oxycodone And Acetaminophen

ANDA 207333, held by Lannett Co Inc. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 207333 (Oxycodone And Acetaminophen), held by Lannett Co Inc, was first approved by FDA on Sep 25, 2017, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2017
Review: Standard
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
Sep 25, 2017	Original application	Approved	REMS Letter

Products

2 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 18REMS	Approved	None posted
Dec 22, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 13REMS	Approved	None posted
Mar 13, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 3REMS	Approved	None posted
Sep 25, 2017	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 207333
Drugs@FDA: Overview at FDA
Company: Lannett Company

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