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Bimatoprost

Sold as Lumigan, Latisse, Durysta, Zolymbus. Every FDA application for this active ingredient: 5 branded and 20 generic.

  • First approved: Mar 16, 2001
  • Applications: 25
  • New uses approved: 2
  • Complete response letters: 0

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
ApprovedApplicationSponsorSupplementsMarketing
Mar 16, 2001LumiganNDA 21275 · New molecular entityAbbvie17Discontinued
Dec 24, 2008LatisseNDA 22369 · New formulation or manufacturerAbbvie11Marketed
Aug 31, 2010LumiganNDA 22184 · New formulation or manufacturerAbbvie7Marketed
Dec 1, 2014BimatoprostANDA 201894Apotex3Discontinued
Feb 20, 2015BimatoprostANDA 203991Lupin4Discontinued
May 5, 2015BimatoprostANDA 202565Sandoz2Marketed
Jul 20, 2015BimatoprostANDA 90449Apotex3Marketed
Apr 19, 2016BimatoprostANDA 202719Sandoz3Marketed
Oct 9, 2018BimatoprostANDA 203051Hikma2Discontinued
Nov 8, 2018BimatoprostANDA 203299Hikma0Discontinued
Mar 22, 2019BimatoprostANDA 210126Gland2Marketed
Apr 12, 2019BimatoprostANDA 210263Alembic2Marketed
Jun 19, 2019BimatoprostANDA 207601Somerset Theraps LLC3Marketed
Jan 21, 2020BimatoprostANDA 210515Alembic2Marketed
Mar 4, 2020DurystaNDA 211911 · New dosage formAbbvie2Marketed
Sep 8, 2020BimatoprostANDA 202505Micro Labs0Marketed
Oct 6, 2022BimatoprostANDA 205537Eugia Pharma0Marketed
Mar 17, 2025BimatoprostANDA 218196Mankind Pharma0Marketed
Sep 9, 2025ZolymbusNDA 217307 · New dosage formThea Pharma0Marketed
Sep 22, 2025BimatoprostANDA 217289Amneal0Marketed
—BimatoprostANDA 200487Sandoz0Discontinued
—BimatoprostANDA 203056Sandoz Inc0Discontinued
—BimatoprostANDA 203404Apotex Inc0Discontinued
—BimatoprostANDA 204638Micro Labs Ltd India0Discontinued
—BimatoprostANDA 209797Gland Pharma Ltd0Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA

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.