Tobramycin And Dexamethasone

   
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Tobramycin And Dexamethasone


Drug - Tobramycin And Dexamethasone
The trade name of the product as shown on the labeling.

Dosage - SUSPENSION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Dexamethasone; Tobramycin
Multiple ingredients are in alphabetical order.

Strength - 0.1%;0.3%
The potency of the active ingredient(s), Dexamethasone; Tobramycin. May repeat for multiple part products.

Applicant - BAUSCH AND LOMB
The firm name holding legal responsibility for Tobramycin And Dexamethasone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 064134
The FDA assigned number to Tobramycin And Dexamethasone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tobramycin And Dexamethasone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Oct 27, 1999
The date Tobramycin And Dexamethasone 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 Tobramycin And Dexamethasone. 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 Tobramycin And Dexamethasone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bausch And Lomb Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Tobramycin And Dexamethasone.

Tobramycin And Dexamethasone