Instant Microspheres

   
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Instant Microspheres


Drug - Instant Microspheres
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Technetium Tc-99m Albumin Microspheres Kit
Multiple ingredients are in alphabetical order.

Strength - N/A
The potency of the active ingredient(s), Technetium Tc-99m Albumin Microspheres Kit. May repeat for multiple part products.

Applicant - 3M
The firm name holding legal responsibility for Instant Microspheres. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017832
The FDA assigned number to Instant Microspheres. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Instant Microspheres. 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 Instant Microspheres 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 Instant Microspheres. 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 Instant Microspheres is in. Format is RX, OTC, DISCN.

Applicant Full Name - 3m Medical Products Div
The full name of the firm holding legal responsibility for the new application of Instant Microspheres.

Instant Microspheres