Oxycodone And Acetaminophen

ANDA 90177, held by Dr Reddys Labs SA. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 90177 (Oxycodone And Acetaminophen), held by Dr Reddys Labs SA, was first approved by FDA on Oct 20, 2008, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2008
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 20, 2008	Original application	Approved	REMS

Products

6 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
Oxycodone And Acetaminophen500MG;7.5MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued
Oxycodone And Acetaminophen650MG;10MG · tablet;oral	Acetaminophen; Oxycodone Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Mar 4, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 12REMS	Approved	None posted
Dec 16, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Apr 14, 2016	Supplement 4Manufacturing	Approved	None posted
Jun 24, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jun 27, 2011	Supplement 2Labeling	Approved	None posted
Oct 20, 2008	Original application	Approved	REMS

Identifiers

Application: ANDA 90177
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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