Loratadine

ANDA 75822, held by Glaxosmithkline. Loratadine.

As of Nov 14, 2026, ANDA 75822 (Loratadine), held by Glaxosmithkline, was first approved by FDA on Feb 10, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 10, 2003
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
Feb 10, 2003	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loratadine10MG · tablet, orally disintegrating;oral	Loratadine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 25, 2008	Supplement 2Labeling	Approved	None posted
Feb 10, 2003	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75822
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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