Ampicillin Trihydrate

ANDA 61502, held by Chartwell Rx. Ampicillin/Ampicillin Trihydrate.

As of Nov 15, 2026, ANDA 61502 (Ampicillin Trihydrate), held by Chartwell Rx, was first approved by FDA on Nov 9, 1971, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1971
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
Nov 9, 1971	Original application	Approved	None posted

Products

2 strengths and forms


Ampicillin TrihydrateEQ 250MG BASE · capsule;oral	Ampicillin/Ampicillin Trihydrate	Discontinued
Ampicillin TrihydrateEQ 500MG BASE · capsule;oral	Ampicillin/Ampicillin Trihydrate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 140Labeling · Standard review	Approved	None posted
Apr 24, 2024	Supplement 138Labeling · Standard review	Approved	None posted
Apr 24, 2024	Supplement 139Labeling · Standard review	Approved	None posted
Jul 7, 2000	Supplement 137Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 136Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 135Manufacturing	Approved	None posted
Nov 5, 1991	Supplement 134Labeling	Approved	None posted
Nov 9, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 61502
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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