← FDA DRUG APPROVALS

FDA NDA · NDA210906

CALCIUM GLUCONATE IN SODIUM CHLORIDE

calcium gluconate

Sponsor: HQ SPCLT PHARMA

APPLICATION
NDA210906
TYPE
NDA
ORIGINAL APPROVAL
2018-10-29
LATEST ACTION
2020-10-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CALCIUM GLUCONATE · ReferencePrescription
CALCIUM GLUCONATE 10GM/100ML (100MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE IN SODIUM CHLORIDE · ReferencePrescription
CALCIUM GLUCONATE 2GM/100ML (20MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE IN SODIUM CHLORIDE · ReferencePrescription
CALCIUM GLUCONATE 1GM/100ML (10MG/ML) · SOLUTION · INTRAVENOUS
CALCIUM GLUCONATE IN SODIUM CHLORIDE · ReferencePrescription
CALCIUM GLUCONATE 1GM/50ML (20MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-10-28Labeling · Supplement 4 · standard — Label ↗AP
2018-10-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →