Allergic Conjunctivitis

• FDA approval · 2020-07-02
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for olopatadine hydrochloride filed by Apotex Corp., enabling changes to the approved product.

• FDA approval · 2020-06-16
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original application for olopatadine hydrochloride (generic), manufactured by Rising Pharma Holdings, Inc., as an approved g…

• FDA approval · 2020-06-01
  FDA Approved: KETOTIFEN FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for ketotifen fumarate as a generic antihistamine product. This mark…

• FDA approval · 2020-05-20
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Rugby Laboratories)

  FDA approved the original ANDA for olopatadine hydrochloride ophthalmic solution (generic) from Rugby Laboratories.

• FDA approval · 2020-05-08
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for azelastine hydrochloride from Aurobindo Pharma Limited.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2020-05-07
  FDA Approved: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for olopatadine hydrochloride ophthalmic solution from Gland Pharma Limited, indicating an updated o…

• FDA approval · 2020-03-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for cetirizine hydrochloride by Bionpharma Inc., under ANDA078488, granting regulatory approval …

• FDA approval · 2020-02-14
  FDA Approved: PATADAY ONCE DAILY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for Pataday Once Daily Relief (olopatadine hydrochloride) from Alcon Laboratories, Inc.

• FDA approval · 2020-02-14
  FDA Approved: PATADAY TWICE A DAY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for Pataday Twice A Day Relief containing olopatadine hydrochloride, expanding its labeling for alle…

• FDA approval · 2020-02-05
  FDA Approved: ZERVIATE — Supplemental Application (Harrow Eye, LLC)

  The FDA approved a supplemental application for ZERVIATE (cetirizine) submitted by Harrow Eye, LLC.

• FDA approval · 2020-01-28
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves the original application for olopatadine hydrochloride, a generic antihistamine used to treat allergic conjunctivitis.

• FDA approval · 2019-08-02
  FDA Approved: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION — Original Application (Gland Pharma Limited)

  FDA approved the original application for olopatadine hydrochloride ophthalmic solution from Gland Pharma Limited, a generic treatment for a…

• FDA approval · 2019-04-29
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's olopatadine hydrochloride as an original application (generic) for ophthalmic use in allergic…

• FDA approval · 2019-04-11
  FDA Approved: NAPHCON A — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for NAPHCON A (naphazoline hydrochloride and pheniramine maleate) from Alcon Laboratories, Inc. The …

• FDA approval · 2019-04-04
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Allwell Health Inc)

  FDA approves Allwell Health Inc's original application for olopatadine hydrochloride, a generic antihistamine for allergic conjunctivitis.

• FDA approval · 2019-03-25
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA has approved a supplemental application for azelastine hydrochloride by Amneal Pharmaceuticals LLC.

• FDA approval · 2019-03-20
  FDA Approved: AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05% — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved a generic azelastine hydrochloride ophthalmic solution 0.05% under an Original Application (ANDA) for Alembic Pharmaceuticals. …

• FDA approval · 2019-03-18
  FDA Approved: BEPOTASTINE BESILATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's original application for bepotastine besilate ophthalmic solution as a generic treatment for allergic conjunctivitis.

• FDA approval · 2019-01-28
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for azelastine hydrochloride from Apotex Corp.

• FDA approval · 2018-12-07
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original ANDA for olopatadine hydrochloride, a generic antihistamine indicated for allergic conjunctiv…

• FDA approval · 2018-10-17
  FDA Approved: VISINE ALLERGY EYE RELIEF MULTI-ACTION — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for Visine Allergy Eye Relief Multi-Action (Naphazoline hydrochloride and pheniramine maleate) f…

• FDA approval · 2018-03-21
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s original ANDA for olopatadine hydrochloride (generic).

• FDA approval · 2018-02-09
  FDA Approved: BEPOTASTINE BESILATE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for BEPOTASTINE BESILATE from Bausch & Lomb Americas Inc.

• FDA approval · 2017-12-05
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Bausch & Lomb Incorporated)

  FDA approved the original application for olopatadine hydrochloride ophthalmic solution from Bausch & Lomb. This antihistamine eye drop is i…

• FDA approval · 2017-12-05
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved the original ANDA for olopatadine hydrochloride ophthalmic solution from Apotex Corp., a generic antihistamine for allergic con…