Lescol Xl

   
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Lescol Xl


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 80MG
The potency of the active ingredient(s), Fluvastatin Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021192
The FDA assigned number to Lescol Xl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lescol Xl. 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 - Oct 6, 2000
The date Lescol Xl 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 Lescol Xl. 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 Lescol Xl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Lescol Xl.

Lescol Xl