Product Information on Aminosyn Ii 3.5% M In Plastic Container 3.5%;32MG/100ML;128MG/100ML;222MG/100ML;49MG/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; Sodium Phosphate, Dibasic, Heptahydrate
Multiple ingredients are in alphabetical order.

Strength - 3.5%;32MG/100ML;128MG/100ML;222MG/100ML;49MG/100ML
The potency of the active ingredient(s), Amino Acids; Magnesium Acetate; Potassium Acetate; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate. May repeat for multiple part products.

Applicant - ABBOTT
The firm name holding legal responsibility for Aminosyn Ii 3.5% M In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019493
The FDA assigned number to Aminosyn Ii 3.5% M In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Aminosyn Ii 3.5% M In 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 - Oct 16, 1986
The date Aminosyn Ii 3.5% M In 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 Aminosyn Ii 3.5% M In Plastic Container. 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 Ii 3.5% M In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Abbott Laboratories Pharmaceutical Products Div
The full name of the firm holding legal responsibility for the new application of Aminosyn Ii 3.5% M In Plastic Container.

Aminosyn Ii 3.5% M In Plastic Container

NewDrugInformation