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FDA NDA · NDA021068

CALCITRIOL

Sponsor: ESJAY PHARMA

APPLICATION
NDA021068
TYPE
NDA
ORIGINAL APPROVAL
1998-11-20
LATEST ACTION
2013-05-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ROCALTROL · ReferencePrescription
CALCITRIOL 1MCG/ML · SOLUTION · ORAL

Approval history

2013-05-15Manufacturing (CMC) · Supplement 8 · standardAP
2004-07-07Labeling · Supplement 2 · standard — Letter ↗AP
2002-02-01Labeling · Supplement 1 · standard — Letter ↗AP
1998-11-20Type 3 - New Dosage Form · 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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