Oxycodone And Acetaminophen

ANDA 207834, held by Chartwell. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 207834 (Oxycodone And Acetaminophen), held by Chartwell, was first approved by FDA on Aug 15, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 15, 2019
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 15, 2019	Original application	Approved	None posted

Products

3 strengths and forms


Oxycodone And Acetaminophen325MG;5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued
Oxycodone And Acetaminophen325MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued
Oxycodone And Acetaminophen325MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Dec 23, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Mar 27, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jan 2, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Aug 15, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 207834
Drugs@FDA: Overview at FDA
Company: Chartwell

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