Oxycodone And Acetaminophen

ANDA 40171, held by Watson Labs. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40171 (Oxycodone And Acetaminophen), held by Watson Labs, was first approved by FDA on Oct 30, 1997, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1997
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Oct 30, 1997	Original application	Approved	REMS

Products

1 strengths and forms

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

All 19 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 42REMS	Approved	None posted
Dec 23, 2025	Supplement 41Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 40REMS	Approved	None posted
Feb 29, 2024	Supplement 38Labeling · Standard review	Approved	None posted
Feb 29, 2024	Supplement 39Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 37Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 36Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 35Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 34Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 33REMS	Approved	None posted
Dec 16, 2016	Supplement 31Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 32Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 30Labeling · Standard review	Approved	None posted
Jul 19, 2011	Supplement 27Labeling	Approved	None posted
Dec 19, 2008	Supplement 19Labeling	Approved	None posted
Apr 12, 2001	Supplement 3Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 21, 1998	Supplement 1Manufacturing	Approved	None posted
Oct 30, 1997	Original application	Approved	REMS

Identifiers

Application: ANDA 40171
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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