Betaxon

   
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Betaxon


Drug - Betaxon
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) - Levobetaxolol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 0.5% BASE
The potency of the active ingredient(s), Levobetaxolol Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021114
The FDA assigned number to Betaxon. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Betaxon. 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 - Feb 23, 2000
The date Betaxon 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 Betaxon. 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 Betaxon is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alcon Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Betaxon.

Betaxon