Ampicillin Trihydrate

ANDA 61601, held by Belcher Pharms. Ampicillin/Ampicillin Trihydrate.

As of Nov 15, 2026, ANDA 61601 (Ampicillin Trihydrate), held by Belcher Pharms, was first approved by FDA on Mar 6, 1974, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 6, 1974
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 6, 1974	Original application	Approved	None posted

Products

2 strengths and forms


Ampicillin TrihydrateEQ 125MG BASE/5ML · for suspension;oral	Ampicillin/Ampicillin Trihydrate	Discontinued
Ampicillin TrihydrateEQ 250MG BASE/5ML · for suspension;oral	Ampicillin/Ampicillin Trihydrate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 22, 1997	Supplement 1Labeling	Approved	None posted
Mar 6, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 61601
Drugs@FDA: Overview at FDA
Company: Belcher Pharmaceuticals

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