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Bimatoprost

ANDA 90449, held by Apotex. Bimatoprost.

  • First approved: Jul 20, 2015
  • 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 20, 2015Original applicationApprovedLabelLetter

Products

1 strengths and forms
ProductActive ingredientMarketing
Bimatoprost0.03% · solution/drops;ophthalmicBimatoprostRx
All 4 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Feb 13, 2024Supplement 7Labeling · Standard reviewApprovedNone posted
Dec 1, 2022Supplement 8Labeling · Standard reviewApprovedNone posted
Nov 20, 2018Supplement 3ManufacturingApprovedNone posted
Jul 20, 2015Original applicationApprovedLabelLetter

Identifiers

Application
ANDA 90449
Company
Apotex

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.