Fortical

NDA 21406, held by Upsher Smith Labs. Calcitonin Salmon Recombinant.

As of Nov 14, 2026, NDA 21406 (Fortical), held by Upsher Smith Labs, was first approved by FDA on Aug 12, 2005, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 12, 2005
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 12, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fortical200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Calcitonin Salmon Recombinant	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 16, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 24, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 9, 2014	Supplement 17Labeling	Approved	Letter
Jul 9, 2014	Supplement 22Labeling · Standard review	Approved	Label Letter
Aug 12, 2011	Supplement 16Labeling	Approved	Letter Label
Jun 22, 2009	Supplement 8Labeling · Standard review	Approved	Letter Label
Feb 2, 2007	Supplement 7Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 3Labeling · Standard review	Approved	Letter Label
Aug 12, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21406
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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