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Travoprost

ANDA 205050, held by Mylan. Travoprost.

  • First approved: Jul 7, 2017
  • Review: Standard
  • Supplements approved: 3
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below
DateSubmissionStatusDocuments
Jul 7, 2017Original applicationApprovedNone posted

Products

1 strengths and forms
ProductActive ingredientMarketing
Travoprost0.004% · solution/drops;ophthalmicTravoprostRx
All 4 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Aug 7, 2024Supplement 12ManufacturingApprovedNone posted
Mar 29, 2024Supplement 3Labeling · Standard reviewApprovedNone posted
Mar 29, 2024Supplement 4Labeling · Standard reviewApprovedNone posted
Jul 7, 2017Original applicationApprovedNone posted

Identifiers

Application
ANDA 205050
Company
Mylan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.