Data updated: Mar 10, 2026
LORATADINE
LORATADINE
Approved 2003-01-21
36
Indications
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2003-01-21
- Routes
- ORAL
- Dosage Forms
- TABLET, SYRUP, TABLET, CHEWABLE, TABLET, ORALLY DISINTEGRATING, CAPSULE, SUSPENSION
Companies
Apotex LANNETT CO INC PERRIGO PHARMA INTL MARKSANS PHARMA PERRIGO RANBAXY LABS LTD TARO UNIQUE PHARM Teva WOCKHARDT BIO AG GSK ONESOURCE SPECIALTY HETERO LABS LTD V RUBICON RESEARCH Aurobindo Pharma Sun Pharma TENSHI SUN PHARMA CANADA PHARM ASSOC PHARMOBEDIENT HETERO LABS LTD III GRANULES CATALENT PHARMA BIONPHARMA ANDA REPOSITORY PLD ACQUISITIONS LLC Viatris
Active Ingredient: LORATADINE
Website: ↗
LORATADINE Approval History
Loading approval history...
What LORATADINE Treats
36 FDA approvalsOriginally approved for its first indication in 2003 . Covers 36 distinct patient populations.
- Other (36)
Other
(36 approvals)- • Approved indication (Jan 2003)Letter
- • Approved indication (Feb 2003)Letter
- • Approved indication (Aug 2003)Letter
- • Approved indication (Aug 2003)Letter
- • Approved indication (Sep 2003)
- • Approved indication (Nov 2003)
- • Approved indication (Nov 2003)Letter
- • Approved indication (Jun 2004)Label Letter
- • Approved indication (Jun 2004)
- • Approved indication (Aug 2004)
- • Approved indication (Oct 2004)
- • Approved indication (Oct 2005)Label Letter
- • Approved indication (Feb 2006)
- • Approved indication (Jun 2006)Letter
- • Approved indication (Nov 2008)Letter
- • Approved indication (Aug 2011)
- • Approved indication (Jul 2015)
- • Approved indication (Sep 2016)Label Letter
- • Approved indication (Apr 2018)
- • Approved indication (Apr 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Jun 2019)
- • Approved indication (Dec 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Sep 2020)Letter
- • Approved indication (Oct 2020)
- • Approved indication (Jan 2021)
- • Approved indication (May 2021)
- • Approved indication (Dec 2022)Label
- • Approved indication (Mar 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Nov 2024)
- • Approved indication (Feb 2025)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LORATADINE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.