Data updated: Nov 8, 2026
OLOPATADINE HYDROCHLORIDE · SCIEGEN PHARMS
Respiratory
Approved 1996-12-18
25
Indications
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Prescription
- First Approved
- 1996-12-18
- Routes
- OPHTHALMIC, NASAL
- Dosage Forms
- SOLUTION/DROPS, SOLUTION, SPRAY, METERED
Companies
SCIEGEN PHARMS EUGIA PHARMA Teva Novartis WATSON LABS BAUSCH AND LOMB INC REGCON HOLDINGS FDC LTD RISING ZAMBON SPA USV GLAND Apotex GLENMARK PHARMS LTD ALEMBIC PADAGIS ISRAEL SOMERSET THERAPS LLC AMNEAL Hikma SOMERSET
Active Ingredient: OLOPATADINE HYDROCHLORIDE
Website: ↗
OLOPATADINE HYDROCHLORIDE Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
51 FDA actions from 2014 to 2026
Jul 2025 ORIGINAL
Update
Feb 2025 ORIGINAL
Update
Dec 2024 ORIGINAL
Update
Aug 2024 SUPPL
Mfg
Apr 2024 SUPPL
Label
Apr 2023 SUPPL
Label
Apr 2023 SUPPL
Label
Nov 2021 SUPPL
Label
Aug 2021 SUPPL
Label
Jun 2021 SUPPL
Label
Apr 2021 SUPPL
Label
Mar 2021 SUPPL
Label
Feb 2021 SUPPL
Label
Feb 2021 SUPPL
Label
Jan 2021 SUPPL
Label
Dec 2020 SUPPL
Label
Aug 2020 ORIGINAL
Update
Aug 2020 SUPPL
Label
Jul 2020 SUPPL
Label
Jul 2020 SUPPL
Label
Jun 2020 ORIGINAL
Update
May 2020 ORIGINAL
Update
May 2020 SUPPL
Label
Jan 2020 ORIGINAL
Update
Sep 2019 ORIGINAL
Update
Aug 2019 ORIGINAL
Update
Apr 2019 ORIGINAL
Update
Apr 2019 ORIGINAL
Update
Dec 2018 ORIGINAL
Update
Mar 2018 ORIGINAL
Update
Dec 2017 ORIGINAL
Update
Jul 2017 ORIGINAL
Update
Jun 2017 ORIGINAL
Update
Jan 2017 ORIGINAL
Update
Jan 2017 ORIGINAL
Update
Dec 2015 ORIGINAL
Update
Oct 2014 ORIGINAL
Update
What OLOPATADINE HYDROCHLORIDE Treats
25 FDA approvalsOriginally approved for its first indication in 2014 . Covers 25 distinct patient populations.
- Other (25)
Other
(25 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)
- • 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)
- • Approved indication (Jan 2026) NewLetter
- • Approved indication (Nov 2026) NewLetter
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01657240 | SOPH118-0112/III | Ph 3 | withdrawn | Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis |
| NCT01344083 | LT1210-PII-04/10 | Ph 2 | completed | Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis |
🔬
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.
OLOPATADINE HYDROCHLORIDE FDA Label Details
Looking for the branded version?
PATANASE
Full clinical data, patents, trials, and competitive landscape for olopatadine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.