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Results For "Sodium-Chloride-Injection"

3 News Found

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection
Drug Approval | October 24, 2025

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable


Dr. Reddy's issues nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL in US
News | March 18, 2025

Dr. Reddy's issues nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL in US

The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles