Sodium Chloride 0.9% In Sterile Plastic Container

   
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Sodium Chloride 0.9% In Sterile Plastic Container


Drug - Sodium Chloride 0.9% In Sterile Plastic Container
The trade name of the product as shown on the labeling.

Dosage - SOLUTION FOR SLUSH; IRRIGATION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Sodium Chloride
Multiple ingredients are in alphabetical order.

Strength - 900MG/100ML
The potency of the active ingredient(s), Sodium Chloride. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE
The firm name holding legal responsibility for Sodium Chloride 0.9% In Sterile Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019319
The FDA assigned number to Sodium Chloride 0.9% In Sterile Plastic Container. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Sodium Chloride 0.9% In Sterile Plastic Container. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - May 17, 1985
The date Sodium Chloride 0.9% In Sterile Plastic Container was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Sodium Chloride 0.9% In Sterile Plastic Container. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Sodium Chloride 0.9% In Sterile Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp
The full name of the firm holding legal responsibility for the new application of Sodium Chloride 0.9% In Sterile Plastic Container.

Sodium Chloride 0.9% In Sterile Plastic Container