Levobunolol Hcl

   
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Levobunolol Hcl


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

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

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

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

Applicant - NOVEX
The firm name holding legal responsibility for Levobunolol Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075475
The FDA assigned number to Levobunolol Hcl. Format is nnnnnn.

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

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

Approval Date - Aug 3, 2000
The date Levobunolol Hcl 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 Levobunolol Hcl. 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 Levobunolol Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novex Pharma
The full name of the firm holding legal responsibility for the new application of Levobunolol Hcl.

Levobunolol Hcl