Oxycodone And Acetaminophen

ANDA 201448, held by Sankalp Lifecare. Acetaminophen; Oxycodone Hydrochloride.

As of Nov 15, 2026, ANDA 201448 (Oxycodone And Acetaminophen), held by Sankalp Lifecare, was first approved by FDA on Aug 26, 2021, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2021
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 26, 2021	Original application	Approved	REMS

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 7REMS	Approved	None posted
Dec 23, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 4REMS	Approved	None posted
Sep 19, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Sep 19, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Aug 26, 2021	Original application	Approved	REMS

Identifiers

Application: ANDA 201448
Drugs@FDA: Overview at FDA
Company: Sankalp Lifecare

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