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As of Nov 15, 2026, NDA 21590 (Fazaclo Odt), held by Jazz, was first approved by FDA on Feb 10, 2004, with 23 approved supplements and 0 published complete response letters.
First approved: Feb 10, 2004
Review: Standard
Supplements approved: 23
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 24 submissions below
Date
Submission
Status
Documents
Feb 10, 2004
Original applicationNew dosage form · Standard review
Fazaclo Odt25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Fazaclo Odt100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Fazaclo Odt50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Fazaclo Odt12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Fazaclo Odt150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Fazaclo Odt200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
