Oxycodone And Acetaminophen

ANDA 90535, held by Sun Pharm Inds Inc. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 90535 (Oxycodone And Acetaminophen), held by Sun Pharm Inds Inc, was first approved by FDA on Dec 26, 2013, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 26, 2013
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 26, 2013	Original application	Approved	REMS

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 14 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 21REMS	Approved	None posted
Dec 23, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 19REMS	Approved	None posted
Feb 29, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Feb 29, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Oct 9, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Sep 20, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 10REMS	Approved	None posted
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Dec 26, 2013	Original application	Approved	REMS

Identifiers

Application: ANDA 90535
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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