Ampicillin Trihydrate

Treats infections caused by susceptible strains of the designated organisms listed below. ANDA 64082, held by Sandoz. Ampicillin/Ampicillin Trihydrate.

As of Nov 15, 2026, ANDA 64082 (Ampicillin Trihydrate), held by Sandoz, was first approved by FDA on Aug 29, 1995, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1995
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules, ampicillin for oral suspension and other antibacterial drugs, ampicillin capsules and ampicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 29, 1995	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	Rx

All 9 submissions, including labeling and manufacturing supplements


Sep 2, 2025	Supplement 23Labeling · Standard review	Approved	None posted
May 1, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Dec 22, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Sep 30, 2004	Supplement 8Labeling	Approved	None posted
Apr 7, 1997	Supplement 4Manufacturing	Approved	None posted
Nov 4, 1996	Supplement 1Manufacturing	Approved	None posted
Nov 4, 1996	Supplement 2Manufacturing	Approved	None posted
Nov 4, 1996	Supplement 3Manufacturing	Approved	None posted
Aug 29, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 64082
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