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FDA ANDA · ANDA078066

CALCITRIOL

Sponsor: LONG GROVE PHARMS

APPLICATION
ANDA078066
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-29
LATEST ACTION
2013-05-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

CALCITRIOLDiscontinued
CALCITRIOL 0.002MG/ML · INJECTABLE · INJECTION
CALCITRIOLPrescription
CALCITRIOL 0.001MG/ML · INJECTABLE · INJECTION

Approval history

2013-05-06Labeling · Supplement 1 · standardAP
2008-01-29OriginalAP
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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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