Baros

NDA 18509, held by Mallinckrodt Inc. Sodium Bicarbonate; Tartaric Acid.

As of Nov 14, 2026, NDA 18509 (Baros), held by Mallinckrodt Inc, was first approved by FDA on Aug 7, 1985, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1985
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 7, 1985	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Baros460MG/GM;420MG/GM · granule, effervescent;oral	Sodium Bicarbonate; Tartaric Acid	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jan 6, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 21, 1992	Supplement 3Labeling	Approved	None posted
May 4, 1987	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 7, 1985	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18509
Drugs@FDA: Overview at FDA
Company: Mallinckrodt

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