Lotrisone

   
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Lotrisone


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

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

Active Ingredient(s) - Betamethasone Dipropionate; Clotrimazole
Multiple ingredients are in alphabetical order.

Strength - EQ 0.05% BASE;1%
The potency of the active ingredient(s), Betamethasone Dipropionate; Clotrimazole. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020010
The FDA assigned number to Lotrisone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lotrisone. 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 - Dec 8, 2000
The date Lotrisone 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 Lotrisone. 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 Lotrisone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Plough Research Institute
The full name of the firm holding legal responsibility for the new application of Lotrisone.

Lotrisone