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Benztropine Mesylate

ANDA 90233, held by Fresenius Kabi USA. Benztropine Mesylate.

  • First approved: Jul 28, 2009
  • Supplements approved: 1
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below
DateSubmissionStatusDocuments
Jul 28, 2009Original applicationApprovedReview

Products

1 strengths and forms
ProductActive ingredientMarketing
Benztropine Mesylate1MG/ML · injectable;injectionBenztropine MesylateRx
All 2 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jul 3, 2023Supplement 4Labeling · Standard reviewApprovedNone posted
Jul 28, 2009Original applicationApprovedReview

Identifiers

Application
ANDA 90233

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.