Timentin

   
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Timentin


Drug - Timentin
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) - Clavulanate Potassium; Ticarcillin Disodium
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL
The potency of the active ingredient(s), Clavulanate Potassium; Ticarcillin Disodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050590
The FDA assigned number to Timentin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Timentin. 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 18, 1987
The date Timentin 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 Timentin. 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 Timentin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Timentin.

Timentin