Probampacin

ANDA 61741, held by Cosette Pharms Nc. Ampicillin/Ampicillin Trihydrate; Probenecid.

As of Nov 15, 2026, ANDA 61741 (Probampacin), held by Cosette Pharms Nc, was first approved by FDA on Oct 10, 1973, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 10, 1973
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
Oct 10, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ProbampacinEQ 3.5GM BASE/BOT;1GM/BOT · for suspension;oral	Ampicillin/Ampicillin Trihydrate; Probenecid	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Oct 10, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 61741
Drugs@FDA: Overview at FDA
Company: Cosette 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