Acetaminophen

ANDA 90205, held by Sun Pharm Inds Ltd. Acetaminophen.

As of Nov 13, 2026, ANDA 90205 (Acetaminophen), held by Sun Pharm Inds Ltd, was first approved by FDA on Nov 18, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 18, 2009
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
Nov 18, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetaminophen650MG · tablet, extended release;oral	Acetaminophen	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 23, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 2Labeling	Approved	None posted
Nov 18, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90205
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