Cesamet

   
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Cesamet


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

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

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

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

New Drug Application (NDA) Number - 018677
The FDA assigned number to Cesamet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cesamet. 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 26, 1985
The date Cesamet 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 Cesamet. 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 Cesamet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Cesamet.

Cesamet