🇺🇸 Topical travoprost in United States

FDA authorised Topical travoprost on 1 March 2013

Marketing authorisations

FDA — authorised 1 March 2013

  • Application: ANDA091340
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 15 May 2014

  • Application: NDA204822
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: IZBA
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 10 July 2015

  • Application: ANDA203431
  • Marketing authorisation holder: APOTEX
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 7 July 2017

  • Application: ANDA205050
  • Marketing authorisation holder: MYLAN
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 20 December 2019

  • Application: ANDA210458
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 19 March 2021

  • Application: ANDA203767
  • Marketing authorisation holder: MICRO LABS
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 3 May 2024

  • Application: ANDA207040
  • Marketing authorisation holder: LUPIN
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 12 July 2024

  • Application: ANDA218159
  • Marketing authorisation holder: GLAND
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 17 December 2025

  • Application: ANDA214687
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: ANDA091341
  • Marketing authorisation holder: PAR PHARM
  • Local brand name: TRAVOPROST
  • Indication: SOLUTION — OPHTHALMIC
  • Status: approved

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Topical travoprost in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Topical travoprost approved in United States?

Yes. FDA authorised it on 1 March 2013; FDA authorised it on 15 May 2014; FDA authorised it on 10 July 2015.

Who is the marketing authorisation holder for Topical travoprost in United States?

CHARTWELL RX holds the US marketing authorisation.