Drug - Amikin
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) - Amikacin Sulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 250MG BASE/ML
The potency of the active ingredient(s), Amikacin Sulfate. May repeat for multiple part products.

Applicant - APOTHECON
The firm name holding legal responsibility for Amikin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062311
The FDA assigned number to Amikin. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Amikin. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Amikin 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) - Yes
The pioneer or innovator of Amikin. 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 Amikin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Amikin.