Oxycodone And Acetaminophen

ANDA 210079, held by Nesher Pharms. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 210079 (Oxycodone And Acetaminophen), held by Nesher Pharms, was first approved by FDA on Dec 28, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 28, 2017
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
Dec 28, 2017	Original application	Approved	None posted

Products

4 strengths and forms


Oxycodone And Acetaminophen325MG;2.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued
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


Mar 4, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Dec 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 210079
Drugs@FDA: Overview at FDA
Company: Nesher Pharmaceuticals

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