Tyzine

   
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Tyzine


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

Dosage - SOLUTION; NASAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.1%
The potency of the active ingredient(s), Tetrahydrozoline Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 086576
The FDA assigned number to Tyzine. Format is nnnnnn.

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

Applicant Full Name - Kenwood Laboratories Div Bradley Pharmaceuticals
The full name of the firm holding legal responsibility for the new application of Tyzine.

Tyzine