FDA Approves ANDA076316 for Sodium Chloride 0.9% Injection

The U.S. Food and Drug Administration (FDA) has approved application number ANDA076316. The approved product is marketed under the brand name Sodium Chloride 0.9% in Plastic Container. It is an injectable solution (INJECTION route) with a dosage form of INJECTABLE and is designated as a prescription product. The formulation contains sodium chloride at a strength of 900 mg per 100 mL. It is not a reference drug and does not rely on a reference standard. The product is identified by product number 001. The submission was made by sponsor GVS TM. It was an original submission (ORIG) with submission number 1 and received an approved (AP) status on 27 October 2004.