Glaucoma

• FDA approval · 2022-04-04
  FDA Approved: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Original Application (Sandoz Inc)

  FDA approves Sandoz Inc's original ANDA for a fixed-dose combination of brimonidine tartrate and timolol maleate to lower intraocular pressu…

• FDA approval · 2022-03-08
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Lumigan (bimatoprost) submitted by Allergan, Inc., resulting in an updated label for the pro…

• FDA approval · 2022-01-31
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Apotex Corp.)

  FDA approved the original application for brimonidine tartrate from Apotex Corp, a generic product used to lower intraocular pressure in gla…

• FDA approval · 2022-01-27
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved the original generic application for dorzolamide hydrochloride from Sagent Pharmaceuticals. The topical solution is used to low…

• FDA approval · 2022-01-25
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Micro Labs Limited)

  FDA approved the preservative-free fixed-dose combination of dorzolamide hydrochloride and timolol maleate under Micro Labs Limited's origin…

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• FDA approval · 2021-12-03
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd.)

  FDA approved a supplemental application for dorzolamide hydrochloride submitted by Advagen Pharma Ltd. The action reflects an approved suppl…

• FDA approval · 2021-11-17
  FDA Approved: TIMOPTIC — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for TIMOPTIC (timolol maleate) submitted by Bausch & Lomb Incorporated.

• FDA approval · 2021-10-28
  FDA Approved: PHOSPHOLINE IODIDE — Supplemental Application (Fera Pharmaceuticals, LLC)

  FDA approved a supplemental application for phospholine iodide (echothiophate iodide for ophthalmic solution) from Fera Pharmaceuticals, LLC…

• FDA approval · 2021-08-23
  FDA Approved: LATANOPROST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LATANOPROST from Sandoz Inc., indicating an approved modification related to this generic produc…

• FDA approval · 2021-08-19
  FDA Approved: ACETAZOLAMIDE — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's generic acetazolamide under an original (ANDA) application, enabling marketing of a generic formulation of…

• FDA approval · 2021-06-09
  FDA Approved: BETOPTIC S — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental NDA for BETOPTIC S (betaxolol hydrochloride) by Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-05-21
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application from Micro Labs Limited for generic dorzolamide hydrochloride and timolol maleate ophthalmic solutio…

• FDA approval · 2021-05-14
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Aurobindo Pharma Limited)

  FDA approved a new generic combination eye drop of dorzolamide hydrochloride and timolol maleate for lowering intraocular pressure in open-a…

• FDA approval · 2021-05-04
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' original application for a generic dorzolamide hydrochloride and timolol maleate ophthalmic solution u…

• FDA approval · 2021-03-16
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for the fixed-dose combination dorzolamide hydrochloride and timolol maleate from Sandoz Inc.

• FDA approval · 2021-02-22
  FDA Approved: ACETAZOLAMIDE — Original Application (TRUPHARMA, LLC)

  The FDA approved an original ANDA for Acetazolamide, a generic version manufactured by TRUPHARMA, LLC.

• FDA approval · 2020-11-23
  FDA Approved: COSOPT — Supplemental Application (Thea Pharma Inc.)

  The FDA approved a supplemental application for COSOPT, the dorzolamide hydrochloride and timolol maleate combination, submitted by Thea Pha…

• FDA approval · 2020-10-01
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Original Application (Micro Labs Limited)

  FDA approved an acetazolamide extended-release product as an original application from Micro Labs Limited.

• FDA approval · 2020-09-21
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal Pharmaceuticals NY LLC's pilocarpine hydrochloride under an original generic application.

• FDA approval · 2020-09-08
  FDA Approved: BIMATOPROST — Original Application (Micro Labs Limited)

  FDA approved the original application for BIMATOPROST from Micro Labs Limited, authorizing a generic version of bimatoprost for reducing int…

• FDA approval · 2020-09-01
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for LATANOPROST submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-08-12
  FDA Approved: BIMATOPROST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for bimatoprost submitted by Sandoz Inc, authorizing an addition/adjustment to the product's app…

• FDA approval · 2020-08-07
  FDA Approved: MITOSOL — Supplemental Application (Mobius Therapeutics LLC)

  FDA approved a supplemental application for MITOSOL (mitomycin C) from Mobius Therapeutics LLC.

• FDA approval · 2020-06-01
  FDA Approved: ROCKLATAN — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for ROCKLATAN (netarsudil and latanoprost ophthalmic solution) submitted by Alcon Laboratories.

• FDA approval · 2020-04-03
  FDA Approved: TIMOLOL MALEATE — Supplemental Application (Pacific Pharma, Inc.)

  FDA approved a supplemental application for timolol maleate from Pacific Pharma, Inc. under the ANDA. The action supplements the existing ap…