Actisite

   
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Actisite


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

Dosage - FIBER, EXTENDED RELEASE; PERIODONTAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Tetracycline Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 12.7MG/FIBER
The potency of the active ingredient(s), Tetracycline Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050653
The FDA assigned number to Actisite. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Actisite. 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 - Mar 25, 1994
The date Actisite 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 Actisite. 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 Actisite is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alza Corp
The full name of the firm holding legal responsibility for the new application of Actisite.

Actisite