← FDA DRUG APPROVALS

FDA NDA · NDA022102

CALOMIST

Sponsor: PH HEALTH

APPLICATION
NDA022102
TYPE
NDA
ORIGINAL APPROVAL
2007-07-27
LATEST ACTION
2020-01-16
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

CALOMISTDiscontinued
CYANOCOBALAMIN 25MCG/SPRAY · SPRAY, METERED · NASAL

Approval history

2020-01-16Labeling · Supplement 4 · standard — Label ↗AP
2009-03-24Manufacturing (CMC) · Supplement 3 — Label ↗AP
2007-07-27Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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