Neo Tect Kit

   
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Neo Tect Kit


Drug - Neo Tect Kit
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 Depreotide
Multiple ingredients are in alphabetical order.

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

Applicant - BERLEX LABS
The firm name holding legal responsibility for Neo Tect Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021012
The FDA assigned number to Neo Tect Kit. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Neo Tect Kit. 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 - Aug 3, 1999
The date Neo Tect Kit 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 Neo Tect Kit. 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 Neo Tect Kit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Berlex Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Neo Tect Kit.

Neo Tect Kit