Oxycodone Hydrochloride And Acetaminophen

ANDA 203573, held by Ph Health. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 203573 (Oxycodone Hydrochloride And Acetaminophen), held by Ph Health, was first approved by FDA on Dec 18, 2014, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 18, 2014
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 18, 2014	Original application	Approved	REMS Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxycodone Hydrochloride And Acetaminophen325MG/5ML;5MG/5ML · solution;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 19REMS	Approved	None posted
Dec 5, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 15REMS	Approved	None posted
Apr 18, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 6REMS · Standard review	Approved	None posted
Dec 16, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Dec 18, 2014	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 203573
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