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FDA NDA · NDA021117

CALCIUM CHLORIDE

Sponsor: HOSPIRA

APPLICATION
NDA021117
TYPE
NDA
ORIGINAL APPROVAL
2000-01-28
LATEST ACTION
2023-05-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 100MG/ML · INJECTABLE · INJECTION

Approval history

2023-05-11Labeling · Supplement 25 · standard — Label ↗AP
2021-08-31Manufacturing (CMC) · Supplement 24 · standard — Label ↗AP
2018-07-25Labeling · Supplement 15 · standard — Letter ↗AP
2003-03-18Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2000-09-01Labeling · Supplement 1 · standardAP
2000-01-28Type 3 - New Dosage Form · 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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