Ampicillin Trihydrate

ANDA 62883, held by Strides Pharma Intl. Ampicillin/Ampicillin Trihydrate.

As of Nov 15, 2026, ANDA 62883 (Ampicillin Trihydrate), held by Strides Pharma Intl, was first approved by FDA on Feb 25, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1988
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 25, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ampicillin TrihydrateEQ 250MG BASE · capsule;oral	Ampicillin/Ampicillin Trihydrate	Discontinued

All 11 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Jul 22, 1997	Supplement 8Labeling	Approved	None posted
Jul 1, 1994	Supplement 7Labeling	Approved	None posted
Mar 31, 1994	Supplement 5Manufacturing	Approved	None posted
Mar 31, 1994	Supplement 6Manufacturing	Approved	None posted
Jan 31, 1994	Supplement 4Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 3Labeling	Approved	None posted
Nov 20, 1991	Supplement 1Manufacturing	Approved	None posted
Nov 20, 1991	Supplement 2Manufacturing	Approved	None posted
Feb 25, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62883
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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