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FDA NDA · NDA021406

FORTICAL

Sponsor: UPSHER SMITH LABS

APPLICATION
NDA021406
TYPE
NDA
ORIGINAL APPROVAL
2005-08-12
LATEST ACTION
2014-09-16
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

FORTICALDiscontinued
CALCITONIN SALMON RECOMBINANT 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2014-09-16Manufacturing (CMC) · Supplement 24 · standardAP
2014-07-24Manufacturing (CMC) · Supplement 23 · standardAP
2014-07-09Labeling · Supplement 22 · standard — Letter ↗AP
2014-07-09Labeling · Supplement 17 · unknown — Letter ↗AP
2011-08-12Labeling · Supplement 16 · unknown — Label ↗AP
2009-06-22Labeling · Supplement 8 · standard — Label ↗AP
2007-02-02Labeling · Supplement 7 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 3 · standard — Label ↗AP
2005-08-12Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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