APPLICATION
ANDA076396
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-17
LATEST ACTION
2015-10-31
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
CALCITONIN-SALMONPrescription
CALCITONIN SALMON 200 IU/SPRAY · SPRAY, METERED · NASAL
Approval history
2015-10-31Labeling · Supplement 5 · standardAP
2015-10-31Labeling · Supplement 6 · standardAP
2012-04-25Labeling · Supplement 3AP
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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