Product Information on Aminosyn 3.5% M 3.5%;21MG/100ML;128MG/100ML;234MG/100ML

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Amino Acids; Magnesium Acetate; Potassium Acetate; Sodium Chloride
Multiple ingredients are in alphabetical order.

Strength - 3.5%;21MG/100ML;128MG/100ML;234MG/100ML
The potency of the active ingredient(s), Amino Acids; Magnesium Acetate; Potassium Acetate; Sodium Chloride. May repeat for multiple part products.

Applicant - HOSPIRA
The firm name holding legal responsibility for Aminosyn 3.5% M. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017789
The FDA assigned number to Aminosyn 3.5% M. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Aminosyn 3.5% M. 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 - Approved Prior to Jan 1, 1982
The date Aminosyn 3.5% M 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 Aminosyn 3.5% M. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Aminosyn 3.5% M is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hospira Inc
The full name of the firm holding legal responsibility for the new application of Aminosyn 3.5% M.

Aminosyn 3.5% M

NewDrugInformation