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FDA NDA · NDA208418

CALCIUM GLUCONATE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA208418
TYPE
NDA
ORIGINAL APPROVAL
2017-06-15
LATEST ACTION
2022-10-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

CALCIUM GLUCONATE · ReferencePrescription
CALCIUM GLUCONATE 10GM/100ML (100MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE · ReferencePrescription
CALCIUM GLUCONATE 1GM/10ML (100MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE IN SODIUM CHLORIDE · ReferenceDiscontinued
CALCIUM GLUCONATE 1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE · ReferencePrescription
CALCIUM GLUCONATE 5GM/50ML (100MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE IN SODIUM CHLORIDE · ReferenceDiscontinued
CALCIUM GLUCONATE 2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2022-10-17Labeling · Supplement 13 · standard — Letter ↗AP
2021-12-29Labeling · Supplement 11 · standard — Letter ↗AP
2021-06-17Labeling · Supplement 7 · standard — Letter ↗AP
2017-12-22Labeling · Supplement 1 · standard — Review ↗AP
2017-06-15Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗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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