Lamisil At

   
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Lamisil At


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

Dosage - SPRAY; TOPICAL
The product dosage form and route separated by a semi-colon.

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

Strength - 1%
The potency of the active ingredient(s), Terbinafine Hydrochloride. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Lamisil At. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021124
The FDA assigned number to Lamisil At. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Lamisil At. 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 - Mar 17, 2000
The date Lamisil At 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 Lamisil At. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Lamisil At is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Consumer Health Inc
The full name of the firm holding legal responsibility for the new application of Lamisil At.

Lamisil At