Paser

ANDA 74346, held by Adaptis. Aminosalicylic Acid.

As of Nov 15, 2026, ANDA 74346 (Paser), held by Adaptis, was first approved by FDA on Jun 30, 1994, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1994
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Paser4GM/PACKET · granule, delayed release;oral	Aminosalicylic Acid	Rx

All 9 submissions, including labeling and manufacturing supplements


Aug 27, 1996	Supplement 11Labeling	Approved	None posted
Aug 27, 1996	Supplement 5Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 4Manufacturing	Approved	None posted
Apr 23, 1996	Supplement 8Manufacturing	Approved	None posted
Feb 21, 1996	Supplement 9Manufacturing	Approved	None posted
Feb 1, 1995	Supplement 3Manufacturing	Approved	None posted
Feb 1, 1995	Supplement 2Manufacturing	Approved	None posted
Feb 1, 1995	Supplement 1Manufacturing	Approved	None posted
Jun 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74346
Drugs@FDA: Overview at FDA
Company: Adaptis

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