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Active ingredient

Olopatadine

114 finished FDA listings contain Olopatadine as their only active ingredient; 2 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
OLOPATADINE HYDROCHLORIDE
Dosage forms
Solution, Solution/ Drops, Spray, Spray, Metered
Routes
Nasal, Ophthalmic
Manufacturers / labelers
53
Strengths listed
1 mg/ml · 2 mg/ml · 5 mg/2.5ml · 665 ug/1 · 7 mg/ml
Brand names in FDA listings
Allergy Relief Eye Drops, Cvs Eye Allergy Itch Relief Once Daily, Cvs Eye Allergy Itch Relief Twice Daily, Equate Olopatadine Hydrochloride, Equate Olopatadine Hydrochloride Ophthalmic Solution, Eye Allergy Itch And Redness Relief, Eye Allergy Itch And Redness Relief Twice Daily Relief, Eye Allergy Itch Relief, Eye Allergy Itch Relief Once Daily Relief, Leader Olopatadine Hydrochloride, Leader Olopatadine Hydrochloride Ophthalmic Solution, Olopatadine Hcl, Olopatadine Hydrochloride, Olopatadine Hydrochloride Ophthalmic Solution, Olopatadine Hydrochloride Ophthalmic Solution Once Daily, Olopatadine Hydrochloride Ophthalmic Solution Twice Daily, Once Daily Relief, Pataday Once Daily Relief, Pataday Twice A Day Relief, Retaine Allergy

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 135391

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020688ALCON LABS INC1996-12-181
NDA 021545ALCON LABS INC2004-12-221
ANDA 091572APOTEX INC2014-10-081
NDA 206276ALCON LABS INC2015-01-301
ANDA 206306SOMERSET THERAPS LLC2015-12-072
ANDA 203152USV2015-12-071
ANDA 078350APOTEX2015-12-073
ANDA 204812EUGIA PHARMA2015-12-1815
ANDA 202853PADAGIS ISRAEL2017-01-313
ANDA 200810GLENMARK PHARMS2017-06-284
ANDA 206046BAUSCH AND LOMB INC2017-07-266
ANDA 090918APOTEX2017-12-051
ANDA 206087BAUSCH AND LOMB INC2017-12-056
ANDA 204392RISING2018-03-211
ANDA 209919ALEMBIC2018-12-073
ANDA 209995EUGIA PHARMA2019-04-0417
ANDA 209420ALEMBIC2019-04-294
ANDA 209619GLAND2019-08-0211
ANDA 210901AMNEAL2020-01-281
ANDA 209752GLAND2020-05-2016
ANDA 204620RISING2020-06-161
ANDA 215006SOMERSET2024-12-181
ANDA 219557GLENMARK PHARMS2025-02-285
ANDA 213514GLAND2026-01-069

Official labeling on DailyMed

Showing the 12 most recent of 108 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.