Acutect

   
Google
 
Web NewDrugInformation.com

Acutect


Drug - Acutect
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 Apcitide
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 020887
The FDA assigned number to Acutect. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acutect. 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 - Sep 14, 1998
The date Acutect 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 Acutect. 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 Acutect 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 Acutect.

Acutect