Ammonium Lactate

ANDA 75575, held by Watson Labs Inc. Ammonium Lactate.

As of Nov 15, 2026, ANDA 75575 (Ammonium Lactate), held by Watson Labs Inc, was first approved by FDA on Jun 11, 2002, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 11, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 11, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ammonium LactateEQ 12% BASE · lotion;topical	Ammonium Lactate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 25, 2008	Supplement 9Labeling	Approved	None posted
May 13, 2003	Supplement 2Labeling	Approved	None posted
Jun 11, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75575
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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