Aminosyn 10%


Aminosyn 10%

Drug - Aminosyn 10%
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Amino Acids
Multiple ingredients are in alphabetical order.

Strength - 10% (10GM/100ML)
The potency of the active ingredient(s), Amino Acids. May repeat for multiple part products.

Applicant - HOSPIRA
The firm name holding legal responsibility for Aminosyn 10%. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017673
The FDA assigned number to Aminosyn 10%. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Aminosyn 10%. 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 10% 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 10%. 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 Aminosyn 10% 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 10%.

Aminosyn 10%