Oxycodone And Acetaminophen

ANDA 40105, held by Ph Health. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 40105 (Oxycodone And Acetaminophen), held by Ph Health, was first approved by FDA on Jul 30, 1996, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1996
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
Jul 30, 1996	Original application	Approved	REMS Review

Products

1 strengths and forms

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

All 18 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 41REMS	Approved	None posted
Oct 31, 2024	Supplement 39REMS	Approved	None posted
Mar 12, 2024	Supplement 38Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 37Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 36Labeling · 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 31REMS · Standard review	Approved	None posted
Dec 16, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 27Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Oct 18, 2013	Supplement 15Labeling · Standard review	Approved	None posted
Jul 21, 2011	Supplement 9Labeling	Approved	None posted
May 29, 2007	Supplement 5Labeling	Approved	None posted
Sep 17, 1997	Supplement 2Manufacturing	Approved	None posted
Sep 17, 1997	Supplement 1Manufacturing	Approved	None posted
Jul 30, 1996	Original application	Approved	REMS Review

Identifiers

Application: ANDA 40105
Drugs@FDA: Overview at FDA
Company: PH Health

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