Principen

ANDA 61394, held by Apothecon. Ampicillin/Ampicillin Trihydrate.

As of Nov 15, 2026, ANDA 61394 (Principen), held by Apothecon, was first approved by FDA on Mar 3, 1971, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 3, 1971
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 3, 1971	Original application	Approved	None posted

Products

3 strengths and forms


PrincipenEQ 100MG BASE/ML · for suspension;oral	Ampicillin/Ampicillin Trihydrate	Discontinued
PrincipenEQ 125MG BASE/5ML · for suspension;oral	Ampicillin/Ampicillin Trihydrate	Discontinued
PrincipenEQ 250MG BASE/5ML · for suspension;oral	Ampicillin/Ampicillin Trihydrate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 30, 1998	Supplement 28Manufacturing	Approved	None posted
Jul 11, 1997	Supplement 27Labeling	Approved	None posted
Feb 29, 1996	Supplement 26Manufacturing	Approved	None posted
Feb 3, 1992	Supplement 25Manufacturing	Approved	None posted
Mar 3, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 61394
Drugs@FDA: Overview at FDA
Company: Apothecon

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