Indium In-111 Oxyquinoline


Indium In-111 Oxyquinoline

Drug - Indium In-111 Oxyquinoline
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) - Indium In-111 Oxyquinoline
Multiple ingredients are in alphabetical order.

Strength - 1mCi/ML
The potency of the active ingredient(s), Indium In-111 Oxyquinoline. May repeat for multiple part products.

The firm name holding legal responsibility for Indium In-111 Oxyquinoline. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019044
The FDA assigned number to Indium In-111 Oxyquinoline. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Indium In-111 Oxyquinoline. 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 - Dec 24, 1985
The date Indium In-111 Oxyquinoline 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 Indium In-111 Oxyquinoline. 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 Indium In-111 Oxyquinoline is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ge Healthcare
The full name of the firm holding legal responsibility for the new application of Indium In-111 Oxyquinoline.

Indium In-111 Oxyquinoline