Data updated: Mar 10, 2026
OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE
Approved 2014-10-08
24
Indications
--
Phase 3 Trials
11
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2014-10-08
- Routes
- OPHTHALMIC, NASAL
- Dosage Forms
- SOLUTION, SOLUTION/DROPS, SPRAY, METERED
Companies
WATSON LABS INC SOMERSET THERAPS LLC Novartis EUGIA PHARMA AMNEAL Apotex BAUSCH AND LOMB INC GLAND Hikma GLENMARK PHARMS INC Teva USV WATSON LABS RISING PADAGIS ISRAEL SCIEGEN PHARMS FLORIDA FDC LTD ALEMBIC ZAMBON SPA SOMERSET
Active Ingredient: OLOPATADINE HYDROCHLORIDE
Website: ↗
OLOPATADINE HYDROCHLORIDE Approval History
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What OLOPATADINE HYDROCHLORIDE Treats
24 FDA approvalsOriginally approved for its first indication in 2014 . Covers 24 distinct patient populations.
- Other (24)
Other
(24 approvals)- • Approved indication (Oct 2014)
- • Approved indication (Jul 2015)Label Letter
- • Approved indication (Dec 2015)Letter
- • Approved indication (Dec 2015)
- • Approved indication (Jan 2017)
- • Approved indication (Jan 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Dec 2017)Letter
- • Approved indication (Mar 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Apr 2019)
- • Approved indication (Apr 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Feb 2020)Letter
- • Approved indication (May 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Dec 2024)
- • Approved indication (Feb 2025)
- • Approved indication (Jul 2025) New
- • Approved indication (Jan 2026) NewLetter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
OLOPATADINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.