Oxycodone And Acetaminophen

ANDA 40535, held by Watson Labs. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40535 (Oxycodone And Acetaminophen), held by Watson Labs, was first approved by FDA on Sep 5, 2003, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2003
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 5, 2003	Original application	Approved	REMS

Products

2 strengths and forms


Oxycodone And Acetaminophen325MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued
Oxycodone And Acetaminophen325MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 18 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 36Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 37Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 35Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 34Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 32Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 33REMS	Approved	None posted
Dec 16, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 31Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 29Labeling · Standard review	Approved	None posted
Jul 19, 2011	Supplement 26Labeling	Approved	None posted
Dec 19, 2008	Supplement 17Labeling	Approved	None posted
Mar 20, 2008	Supplement 11Manufacturing	Approved	None posted
Sep 5, 2003	Original application	Approved	REMS

Identifiers

Application: ANDA 40535
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