Loratadine

ANDA 75209, held by Pld Acquisitions LLC. Loratadine.

As of Nov 14, 2026, ANDA 75209 (Loratadine), held by Pld Acquisitions LLC, was first approved by FDA on Jan 21, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 21, 2003
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jan 21, 2003	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loratadine10MG · tablet;oral	Loratadine	OTC

All 4 submissions, including labeling and manufacturing supplements


Mar 10, 2010	Supplement 19Manufacturing	Approved	None posted
Mar 20, 2009	Supplement 18Labeling	Approved	None posted
Oct 29, 2003	Supplement 2Labeling	Approved	None posted
Jan 21, 2003	Original application	Approved	Letter

Identifiers

Application: ANDA 75209
Drugs@FDA: Overview at FDA
Company: PLD Acquisitions

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