Acetaminophen

ANDA 204052, held by Sandoz. Acetaminophen.

As of Nov 13, 2026, ANDA 204052 (Acetaminophen), held by Sandoz, was first approved by FDA on Mar 22, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2016
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 22, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetaminophen1GM/100ML (10MG/ML) · solution;intravenous	Acetaminophen	Rx

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 24, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Oct 31, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Mar 22, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204052
Drugs@FDA: Overview at FDA
Company: Sandoz

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