Lotrimin Ultra

   
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Lotrimin Ultra


Drug - Lotrimin Ultra
The trade name of the product as shown on the labeling.

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

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

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

Applicant - SCHERING PLOUGH
The firm name holding legal responsibility for Lotrimin Ultra. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021307
The FDA assigned number to Lotrimin Ultra. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lotrimin Ultra. 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 - Dec 7, 2001
The date Lotrimin Ultra 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 Lotrimin Ultra. 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 Lotrimin Ultra is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Plough Healthcare Products Inc
The full name of the firm holding legal responsibility for the new application of Lotrimin Ultra.

Lotrimin Ultra