Amoxicillin

ANDA 65113, held by Sun Pharm Inds Ltd. Amoxicillin.

As of Nov 14, 2026, ANDA 65113 (Amoxicillin), held by Sun Pharm Inds Ltd, was first approved by FDA on Nov 29, 2002, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 29, 2002
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 29, 2002	Original application	Approved	None posted

Products

2 strengths and forms


Amoxicillin200MG/5ML · for suspension;oral	Amoxicillin	Discontinued
Amoxicillin400MG/5ML · for suspension;oral	Amoxicillin	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 30, 2008	Supplement 10Labeling	Approved	None posted
Jul 31, 2006	Supplement 5Labeling	Approved	None posted
May 4, 2006	Supplement 4Labeling	Approved	None posted
Nov 29, 2005	Supplement 3Labeling	Approved	None posted
Apr 23, 2004	Supplement 1Labeling	Approved	None posted
Nov 29, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 65113
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