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FDA NDA · NDA207174

PARICALCITOL

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA207174
TYPE
NDA
ORIGINAL APPROVAL
2016-02-04
LATEST ACTION
2019-10-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PARICALCITOLPrescription
PARICALCITOL 0.01MG/2ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLPrescription
PARICALCITOL 0.002MG/ML (0.002MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLPrescription
PARICALCITOL 0.005MG/ML (0.005MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2019-10-17Labeling · Supplement 6 · standard — Label ↗AP
2016-02-04Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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