Loratadine

Sold as Claritin, Claritin Hives Relief, Claritin Reditabs, Claritin Hives Relief Reditab, Alavert and 2 more. Every FDA application for this active ingredient: 9 branded and 38 generic.

As of Nov 14, 2026, FDA lists 47 applications for Loratadine (sold as Claritin, Claritin Hives Relief, Claritin Reditabs and others), first approved Apr 12, 1993, with 10 new uses approved and 0 published complete response letters.

First approved: Apr 12, 1993
Applications: 47
New uses approved: 10
Complete response letters: 0

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitisMar 4, 2020 · boxed warning

Clinical Trials

11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Zuberitamab in the First Episode of Paediatric Nephrotic SyndromeNephrotic Syndrome · Children's Hospital of Fudan University	Phase 3	Not yet recruiting	Aug 14, 2026
Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)Solid Tumors · Val Adams	Phase 2	Recruiting	Jun 22, 2026
Efficacy of Auricular Acupressure Combined With Antihistamines in Patients With Wind-Heat Type Urticaria.Auricular Acupressure, Wind-Heat Urticaria · University of Medicine and Pharmacy at Ho Chi Minh City	Not applicable	Not yet recruiting	May 8, 2026
A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)Chronic Spontaneous Urticaria (CSU) · The Fourth Affiliated Hospital of Zhejiang University School of Medicine	—	Not yet recruiting	Apr 30, 2026
Comparison of Antihistamine and Antileukotriene Add-On Therapy to Intranasal Corticosteroid in Allergic RhinitisAllergic Rhinitis (AR) · Liaquat National Hospital & Medical College	Phase 4	Not yet recruiting	Apr 16, 2026
Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood CancersHematologic Malignancy, Neutropenia · Alexandria University	Not applicable	Recruiting	Dec 24, 2025
Efficacy of Buteyko Breathing in Seniors With Chronic Eustachian Tube DysfunctionEustachian Tube Dysfunction · Cairo University	Not applicable	Recruiting	Sep 25, 2025
Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE TrialMultiple Myeloma · Emory University	Phase 4	Recruiting	Aug 3, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 12, 1993	Claritin, Claritin Hives ReliefNDA 19658 · New molecular entity	Bayer Healthcare LLC	34	Marketed
Oct 10, 1996	Claritin, Claritin Hives ReliefNDA 20641 · New dosage form	Bayer Healthcare LLC	28	Marketed
Dec 23, 1996	Claritin Reditabs, Claritin Hives Relief ReditabNDA 20704 · New dosage form	Bayer Healthcare LLC	19	Marketed
Dec 19, 2002	AlavertNDA 21375 · New dosage form	Fdn Consumer	1	Marketed
Jan 21, 2003	LoratadineANDA 75209	Pld Acquisitions LLC	3	Marketed
Feb 10, 2003	LoratadineANDA 75822	Glaxosmithkline	1	Discontinued
Aug 18, 2003	LoratadineANDA 76134	Sun Pharm Inds Ltd	3	Marketed
Aug 20, 2003	LoratadineANDA 76154	Mylan	0	Marketed
Sep 29, 2003	LoratadineANDA 76011	Perrigo Pharma Intl	0	Marketed
Nov 3, 2003	LoratadineANDA 75990	Actavis Labs Fl Inc	0	Discontinued
Nov 7, 2003	LoratadineANDA 75505	Teva	0	Discontinued
Jun 24, 2004	LoratadineNDA 21512 · New dosage form	Perrigo	0	Discontinued
Jun 25, 2004	LoratadineANDA 76301	Perrigo	2	Marketed
Aug 20, 2004	LoratadineANDA 75728	Perrigo	1	Marketed
Aug 20, 2004	LoratadineANDA 75815	Wockhardt Bio AG	0	Marketed
Aug 20, 2004	LoratadineANDA 76529	Ranbaxy Labs Ltd	0	Discontinued
Aug 20, 2004	LoratadineANDA 76805	Taro	6	Marketed
Oct 5, 2004	LoratadineANDA 75565	Pharm Assoc	0	Marketed
Oct 4, 2005	LoratadineNDA 21734 · New dosage form	Sun Pharma Canada	0	Discontinued
Feb 14, 2006	LoratadineANDA 76471	Apotex	0	Marketed
Jun 29, 2006	LoratadineANDA 77421	Lannett Co Inc	2	Marketed
Aug 23, 2006	Children'S Claritin, ClaritinNDA 21891 · New dosage form	Bayer Healthcare LLC	26	Marketed
Dec 12, 2006	Claritin ReditabsNDA 21993 · New formulation or manufacturer	Bayer Healthcare LLC	6	Marketed
Apr 11, 2007	Loratadine RedidoseANDA 77153	Sun Pharm Inds Ltd	2	Marketed
Jun 16, 2008	ClaritinNDA 21952 · New dosage form	Bayer Healthcare LLC	9	Marketed
Nov 7, 2008	LoratadineANDA 75790	Pharmazone	0	Discontinued
Aug 12, 2011	LoratadineANDA 78447	Pharmobedient	0	Discontinued
Jul 31, 2015	LoratadineANDA 201865	Taro	0	Marketed
Sep 23, 2016	LoratadineANDA 206214	Pharmazone	0	Marketed
Apr 11, 2018	LoratadineANDA 208477	Aurobindo Pharma Ltd	1	Marketed
Apr 16, 2018	LoratadineANDA 208314	Aurobindo Pharma Ltd	0	Marketed
Apr 16, 2018	LoratadineANDA 210088	Sun Pharm	3	Marketed
Jun 29, 2018	LoratadineANDA 208931	Aurobindo Pharma Ltd	0	Marketed
Dec 21, 2018	LoratadineANDA 202538	Bionpharma	0	Marketed
Mar 12, 2019	LoratadineANDA 207569	Adaptis	0	Marketed
Jun 12, 2019	LoratadineANDA 210033	Perrigo Pharma Intl	0	Marketed
Dec 23, 2019	LoratadineANDA 210722	Granules	0	Marketed
Jan 15, 2020	LoratadineANDA 211926	Onesource	0	Discontinued
Sep 10, 2020	LoratadineANDA 214280	Rubicon Research	0	Marketed
Sep 18, 2020	LoratadineANDA 212795	Instapill	0	Marketed
Oct 30, 2020	LoratadineANDA 213294	Instapill	0	Marketed
Jan 7, 2021	LoratadineANDA 214684	Unique Pharm	0	Marketed
May 7, 2021	LoratadineANDA 210409	Hetero Labs Ltd Iii	0	Marketed
Mar 24, 2023	LoratadineANDA 211900	Aurobindo Pharma	0	Marketed
Jul 28, 2023	LoratadineANDA 211718	Hetero Labs Ltd V	0	Marketed
Nov 21, 2024	LoratadineANDA 219223	Pharmazone	0	Marketed
Feb 28, 2025	LoratadineANDA 215127	Catalent Pharma	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA