Allergic Conjunctivitis

• FDA approval · 2023-04-05
  FDA Approved: BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% from Alembic Pharmaceuticals as an original application for the treatment of itch…

• FDA approval · 2022-12-19
  FDA Approved: NAPHCON A — Supplemental Application (Alcon Laboratories, Inc.)

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

• FDA approval · 2022-11-02
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic promethazine hydrochloride under an original ANDA. The approval authorizes marketing of the gen…

• FDA approval · 2022-09-23
  FDA Approved: EYE ALLERGY RELIEF — Supplemental Application (DOLGENCORP, LLC)

  FDA approved a supplemental application for Eye Allergy Relief (pheniramine maleate and naphazoline hydrochloride) from DolgenCorp, LLC. The…

• FDA approval · 2022-08-29
  FDA Approved: LASTACAFT — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for LASTACAFT (alcaftadine) from Allergan, Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-08-02
  FDA Approved: FLAREX — Supplemental Application (Eyevance Pharmaceuticals)

  FDA approved a supplemental application for FLAREX (fluorometholone acetate) submitted by Eyevance Pharmaceuticals.

• FDA approval · 2021-12-10
  FDA Approved: LASTACAFT — Supplemental Application (Allergan, Inc.)

  FDA approves a supplemental application for LASTACAFT (alcaftadine) submitted by Allergan, Inc.

• FDA approval · 2021-11-16
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for olopatadine hydrochloride from Padagis Israel Pharmaceuticals Ltd, reflecting changes to an exis…

• FDA approval · 2021-10-25
  FDA Approved: PATADAY ONCE DAILY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approves a supplemental application for Pataday Once Daily Relief (olopatadine hydrochloride) by Alcon Laboratories, expanding the label…

• FDA approval · 2021-08-26
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (GLENMARK THERAPEUTICS INC., USA)

  The FDA approved Glenmark Therapeutics' supplemental application for olopatadine hydrochloride ophthalmic solution, updating the product lab…

• FDA approval · 2021-05-13
  FDA Approved: PATADAY ONCE DAILY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for Pataday Once Daily Relief (olopatadine hydrochloride) by Alcon Laboratories, expanding the produ…

• FDA approval · 2021-04-30
  FDA Approved: AZELASTINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approves a supplemental application for azelastine submitted by Ascend Laboratories, LLC.

• FDA approval · 2021-04-14
  FDA Approved: EYE ITCH RELIEF — Supplemental Application (Target Corporation)

  The FDA approved a supplemental application for Eye Itch Relief containing ketotifen fumarate from Target Corporation.

• FDA approval · 2021-04-02
  FDA Approved: OLOPATADINE HCL — Supplemental Application (Sola Pharmaceuticals)

  FDA supplemental application submission for olopatadine hydrochloride by Sola Pharmaceuticals.

• FDA approval · 2021-03-19
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for olopatadine hydrochloride ophthalmic solution from Bausch & Lomb, updating the product label…

• FDA approval · 2021-02-18
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for olopatadine hydrochloride, updating an already-approved product. The appr…

• FDA approval · 2021-01-25
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's supplemental application for olopatadine hydrochloride (ANDA209420), authorizing changes unde…

• FDA approval · 2020-12-18
  FDA Approved: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approves a supplemental application for olopatadine hydrochloride ophthalmic solution by Bausch & Lomb, updating the product's approval.

• FDA approval · 2020-09-30
  FDA Approved: PATADAY TWICE A DAY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for Pataday Twice a Day Relief (olopatadine hydrochloride) by Alcon Laboratories, expanding labe…

• FDA approval · 2020-09-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approved the original generic application for cetirizine hydrochloride to be marketed by Aurohealth LLC.

• FDA approval · 2020-08-06
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for olopatadine hydrochloride (generic ophthalmic antihistamine). The approval cov…

• FDA approval · 2020-07-15
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for olopatadine hydrochloride from Rising Pharma Holdings, Inc. The approval entails changes to …

• FDA approval · 2020-07-15
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Allwell Health Inc)

  The FDA approved a supplemental application for the generic olopatadine hydrochloride from Allwell Health Inc under ANDA209995. The action u…

• FDA approval · 2020-07-15
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Harris Teeter)

  FDA approved a supplemental application for olopatadine hydrochloride, a generic antihistamine eye drop, for Harris Teeter.

• FDA approval · 2020-07-13
  FDA Approved: PATADAY ONCE DAILY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application to allow Pataday Once Daily Relief (olopatadine hydrochloride) for once-daily dosing in allergic…