Glaucoma

• FDA label_change · 2024-07-18
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Micro Labs Limited)

  The FDA approved a supplemental application from Micro Labs Limited for a preservative-free dorzolamide hydrochloride and timolol maleate pr…

• FDA label_change · 2024-01-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for acetazolamide by Hikma Pharmaceuticals USA Inc., resulting in labeling and/or manufacturing chan…

• FDA label_change · 2021-06-22
  FDA Approved: BRINZOLAMIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for brinzolamide by Sandoz Inc. to update the product labeling. The update may reflect changes to in…

• FDA label_change · 2020-02-21
  FDA Approved: LATANOPROST — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for latanoprost submitted by Bausch & Lomb Incorporated.

• FDA label_change · 2016-06-16
  FDA Approved: BETOPTIC S — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for BETOPTIC S (betaxolol hydrochloride) submitted by Novartis, resulting in labeling changes fo…

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• FDA label_change · 2016-03-24
  FDA Approved: BETOPTIC S — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Betoptic S (betaxolol hydrochloride) from Novartis, updating the drug's labeling.

• FDA label_change · 2016-03-11
  FDA Approved: TRAVATAN Z — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Travatan Z (travoprost) from Novartis Pharmaceuticals Corporation. This action updates the produ…

• FDA label_change · 2016-01-21
  FDA Approved: MIOSTAT — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for MIOSTAT (carbachol) from Alcon Laboratories, Inc., updating the labeling for its ocular use.

• FDA label_change · 2016-01-15
  FDA Approved: SIMBRINZA — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for SIMBRINZA (brinzolamide/brimonidine tartrate) to update the product labeling.

• FDA label_change · 2015-10-06
  FDA Approved: TIMOLOL MALEATE — Supplemental Application (Pacific Pharma, Inc.)

  FDA approved a supplemental application for timolol maleate from Pacific Pharma, Inc. to update the drug’s labeling.

• FDA label_change · 2015-08-14
  FDA Approved: TIMOPTIC IN OCUDOSE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for TIMOPTIC IN OCUDOSE (timolol maleate) from Bausch & Lomb Incorporated.

• FDA label_change · 2014-12-19
  FDA Approved: BETAXOLOL HYDROCHLORIDE — Supplemental Application (KVK-TECH, INC.)

  FDA approved a supplemental application for betaxolol hydrochloride from KVK-Tech, Inc., resulting in changes to the drug's labeling.

• FDA label_change · 2013-02-22
  FDA Approved: TAFLUPROST OPHTHALMIC — Supplemental Application (Prasco Laboratories)

  FDA supplemental application for Tafluprost Ophthalmic submitted by Prasco Laboratories, likely seeking changes to the product labeling. Thi…

• FDA label_change · 2006-06-05
  FDA Approved: TIMOPTIC IN OCUDOSE — Supplemental Application (Bausch & Lomb Incorporated)

  This document concerns a supplemental application for Timoptic in Ocudose (timolol maleate) filed by Bausch & Lomb Incorporated.